Advanced Colorectal CarcinomaLOTUSNCT06073431
LOTUS-CC: An Observational Research Study to Uncover Subtypes of Cancer Cachexia
An observational study of Advanced Colorectal Carcinoma and Advanced Lung Non-Small Cell Carcinoma, run by University of Rochester at 225 sites in United States.
Trial summary
This study evaluates cancer-related weight and muscle mass loss, symptoms, and physical function (cachexia) in patients undergoing treatment for colorectal, lung, or pancreatic cancer that cannot be removed by surgery (unresectable) or is stage IV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Colorectal Carcinoma, Advanced Lung Non-Small Cell Carcinoma, Advanced Pancreatic Adenocarcinoma
- What is being tested?
- Biospecimen Collection, Computed Tomography and Electronic Health Record Review
- Type of treatment
- Surgery or procedure
- How many people
- 800 participants
- Where
- 225 sitesUnited States
- Study dates
- 4 Dec 2023to 30 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing treatment for non-small cell lung cancer (NSCLC), pancreatic adenocarcinoma, colorectal cancer.
Who may be able to join
- Have a primary diagnosis of unresectable or stage IV 1) non-small cell lung cancer (NSCLC), 2) pancreatic adenocarcinoma, or 3) colorectal cancer
- Note: Patients do not need to have cachexia to be eligible
- Plan to start first-line systemic anti-cancer therapy (chemotherapy, immunotherapy, targeted therapy, interventional clinical trial) in the next 6 weeks or has started first-line systemic therapy in the previous 6 weeks.
- NOTE: Patients who received systemic anti-cancer therapy previously as part of adjuvant or neoadjuvant treatment and have since recurred are still eligible if such treatment ended > 6 months prior to enrollment. Patients receiving concurrent radiation with systemic therapy or received local therapy alone (surgery, radiation therapy [RT]) prior to first line therapy remain eligible. Patients receiving maintenance treatment after first line therapy are not eligible
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- Be able to understand, speak and read English
- Be 18 years of age or older
Who cannot join
- Have contraindications to physical function assessments (30-second arm curl, Timed-Up-And-Go test, or 30-second chair-stand test) per the treating provider or their designee
- Have any planned major surgeries within the next 3 months
- Have received chemotherapy or surgery for separate primary cancer within the past 3 years other than early local staged non-melanoma skin cancer
- Be pregnant
Trial locations and contacts
225 sites in 1 country. Contact the study team or a site near you to ask about taking part.
225 sites in 1 country
United States225 sites, 196 recruiting
- Recruiting
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, 96701
Site Public Contact, 808-539-2273, info@hawaiicancercare.com
Jared D. Acoba
- Recruiting
Pali Momi Medical Center
‘Aiea, Hawaii, 96701
Site Public Contact, 808-486-6000
Jared D. Acoba
- Recruiting
Queen's Cancer Center - Pearlridge
‘Aiea, Hawaii, 96701
Site Public Contact, 808-487-7447
Jared D. Acoba
- Recruiting
The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii, 96706
Site Public Contact, rohta@queens.org
Jared D. Acoba
- Recruiting
OSF Saint Anthony's Health Center
Alton, Illinois, 62002
Site Public Contact, 618-463-5623
Jay W. Carlson
- Recruiting
AnMed Health Cancer Center
Anderson, South Carolina, 29621
Site Public Contact, 864-512-4651, rhonda.ballew@anmedhealth.org
Leander Cannick
- Recruiting
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
Site Public Contact, 920-364-3604, ResearchDept@thedacare.org
Julia Stoffel
- Recruiting
Ascension Saint Elizabeth Hospital
Appleton, Wisconsin, 54915
Site Public Contact, AWRI.inquiry@ascension.org
Bradley C. Heraly
- Recruiting
Northside Hospital
Atlanta, Georgia, 30342
Site Public Contact, 404-303-3355, ClinicalTrials@northside.com
Aldemar Montero
- Active, not recruiting
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012
- Recruiting
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010
Site Public Contact, 847-842-4847
Thomas J. Saphner
- Active, not recruiting
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431
- Recruiting
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
Site Public Contact, 360-788-8223
Alison K. Conlin
- Recruiting
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- Recruiting
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Saint Joseph's/Candler - Bluffton Campus
Bluffton, South Carolina, 29910
Site Public Contact, 912-819-5704, underberga@sjchs.org
Mark A. Taylor
- Active, not recruiting
Saint Elizabeth Boardman Hospital
Boardman, Ohio, 44512
- Active, not recruiting
Boulder Community Foothills Hospital
Boulder, Colorado, 80303
- Active, not recruiting
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304
- Recruiting
Northeast Georgia Medical Center Braselton
Braselton, Georgia, 30517
Site Public Contact, 770-219-8800, cancerpatient.navigator@nghs.com
Andrew T. Johnson
- Recruiting
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Brookfield, Wisconsin, 53045
Site Public Contact, AWRI.Inquiry@Ascension.org
Bradley C. Heraly
- Recruiting
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Recruiting
Illinois CancerCare-Canton
Canton, Illinois, 61520
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902
Site Public Contact, 618-457-5200, clinical.research@sih.net
Bryan A. Faller
- Recruiting
Carson Tahoe Regional Medical Center
Carson City, Nevada, 89703
Site Public Contact, 702-384-0013, research@sncrf.org
Khawaja S. Jahangir
- Recruiting
SIH Cancer Institute
Carterville, Illinois, 62918
Site Public Contact, 618-985-3333, clinical.research@sih.net
Bryan A. Faller
- Recruiting
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Active, not recruiting
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado, 80112
- Recruiting
Centralia Oncology Clinic
Centralia, Illinois, 62801
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
Site Public Contact, 773-296-5360
Thomas J. Saphner
- Recruiting
Ascension Calumet Hospital
Chilton, Wisconsin, 53014
Site Public Contact, AWRI.inquiry@ascension.org
Bradley C. Heraly
- Active, not recruiting
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236
- Recruiting
John B Amos Cancer Center
Columbus, Georgia, 31904
Site Public Contact, 706-478-7968, cdean@iacthealth.com
Andrew W. Pippas
- Recruiting
Mercy Hospital
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Recruiting
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, 60014
Site Public Contact, 630-929-6129, advocateresearch@advocate.com
Thomas J. Saphner
- Recruiting
Aurora Saint Luke's South Shore
Cudahy, Wisconsin, 53110
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Noyes Memorial Hospital/Myers Cancer Center
Dansville, New York, 14437
Site Public Contact, WCICTOresearch@urmc.rochester.edu
Po-Ju Lin
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Priyank P. Patel
- Recruiting
Geisinger Medical Center
Danville, Pennsylvania, 17822
Site Public Contact, 570-271-5251, HemonCCTrials@geisinger.edu
Nadia N. Ramdin
- Active, not recruiting
Dayton Physician LLC - Englewood
Dayton, Ohio, 45415
- Recruiting
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Decatur Memorial Hospital
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Active, not recruiting
The Women's Imaging Center
Denver, Colorado, 80209
- Active, not recruiting
Colorado Blood Cancer Institute
Denver, Colorado, 80218
- Active, not recruiting
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, 80218
- Active, not recruiting
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, 80220
- Recruiting
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
Site Public Contact, 815-285-7800
Bryan A. Faller
- Recruiting
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
Site Public Contact, 630-275-1270, Barbara.barhamand@advocatehealth.com
Thomas J. Saphner
- Recruiting
Northside Hospital - Duluth
Duluth, Georgia, 30096
Site Public Contact, 404-303-3355, Clinical.trials@northside.com
Aldemar Montero
- Suspended
HSHS Sacred Heart Hospital
Eau Claire, Wisconsin, 54701
- Recruiting
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Dean A. Delmastro
- Recruiting
Fairview Southdale Hospital
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Recruiting
Crossroads Cancer Center
Effingham, Illinois, 62401
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Advocate Sherman Hospital
Elgin, Illinois, 60123
Site Public Contact, 847-429-2907
Thomas J. Saphner
- Recruiting
Christiana Care - Union Hospital
Elkton, Maryland, 21921
Site Public Contact, 410-443-1360, frank.crum@christianacare.org
Gregory A. Masters
- Active, not recruiting
Rocky Mountain Cancer Centers - Swedish
Englewood, Colorado, 80113
- Active, not recruiting
The Melanoma and Skin Cancer Institute
Englewood, Colorado, 80113
- Recruiting
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Parkland Health Center - Farmington
Farmington, Missouri, 63640
Site Public Contact, 314-996-5569
Bryan A. Faller
- Active, not recruiting
Armes Family Cancer Center
Findlay, Ohio, 45840
- Active, not recruiting
Blanchard Valley Hospital
Findlay, Ohio, 45840
- Recruiting
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
Site Public Contact, 800-378-9373
Jay W. Carlson
- Active, not recruiting
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005
- Recruiting
Ascension Saint Francis - Reiman Cancer Center
Franklin, Wisconsin, 53132
Site Public Contact, AWRI.Inquiry@Ascension.org
Bradley C. Heraly
- Recruiting
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341
Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org
Michael Humeniuk
- Recruiting
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia, 30501
Site Public Contact, 770-219-8800, cancerpatient.navigator@nghs.com
Andrew T. Johnson
- Recruiting
The Longstreet Clinic - Gainesville
Gainesville, Georgia, 30501
Site Public Contact, 770-219-9010
Andrew T. Johnson
- Recruiting
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Brian L. Burnette
- Recruiting
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
Site Public Contact, 920-433-8889, wi_research_admin@hshs.org
Brian L. Burnette
- Recruiting
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Aurora Health Center - Greenfield
Greenfield, Wisconsin, 53228
Site Public Contact, 414-302-2304, ncorp@aah.org
Thomas J. Saphner
- Active, not recruiting
Wayne Hospital
Greenville, Ohio, 45331
- Recruiting
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651
Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org
Michael Humeniuk
- Recruiting
Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429
Site Public Contact, 708-799-9995
Thomas J. Saphner
- Recruiting
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, 89052
Site Public Contact, 702-384-0013, research@sncrf.org
Khawaja S. Jahangir
- Recruiting
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, 89052
Site Public Contact, 702-384-0013, research@sncrf.org
Khawaja S. Jahangir
- Recruiting
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, 89074
Site Public Contact, 702-384-0013, research@sncrf.org
Khawaja S. Jahangir
- Recruiting
Urology Specialists of Nevada - Green Valley
Henderson, Nevada, 89074
Site Public Contact, research@sncrf.org
Khawaja S. Jahangir
- Recruiting
South Carolina Cancer Specialists PC
Hilton Head Island, South Carolina, 29926-3827
Site Public Contact, 912-819-5704, underberga@sjchs.org
Mark A. Taylor
- Recruiting
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813
Site Public Contact, 808-524-6115, i.webster@hawaiicancercare.com
Jared D. Acoba
- Recruiting
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, 96813
Site Public Contact, 808-532-0315
Jared D. Acoba
- Recruiting
Queen's Medical Center
Honolulu, Hawaii, 96813
Site Public Contact, 808-545-8548
Jared D. Acoba
- Recruiting
Straub Clinic and Hospital
Honolulu, Hawaii, 96813
Site Public Contact, 808-522-4333
Jared D. Acoba
- Recruiting
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, 96817
Site Public Contact, 808-531-8521
Jared D. Acoba
- Recruiting
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
Site Public Contact, 808-983-6090
Jared D. Acoba
- Recruiting
Dickinson County Healthcare System
Iron Mountain, Michigan, 49801
Site Public Contact, 906-774-1313, oncology.clinical.trials@marshfieldresearch.org
Dean A. Delmastro
- Recruiting
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Active, not recruiting
Greater Dayton Cancer Center
Kettering, Ohio, 45409
- Active, not recruiting
Kettering Medical Center
Kettering, Ohio, 45429
- Recruiting
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042
Site Public Contact, 516-734-8896
Vincent P. Vinciguerra
- Active, not recruiting
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, 80228
- Recruiting
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102
Site Public Contact, 702-384-0013, research@sncrf.org
Khawaja S. Jahangir
- Recruiting
Urology Specialists of Nevada - Southwest
Las Vegas, Nevada, 89113
Site Public Contact, research@sncrf.org
Khawaja S. Jahangir
- Recruiting
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, 89128
Site Public Contact, 702-384-0013, research@sncrf.org
Khawaja S. Jahangir
- Recruiting
OptumCare Cancer Care at MountainView
Las Vegas, Nevada, 89128
Site Public Contact, 702-384-0013, research@sncrf.org
Khawaja S. Jahangir
- Recruiting
Urology Specialists of Nevada - Northwest
Las Vegas, Nevada, 89128
Site Public Contact, research@sncrf.org
Khawaja S. Jahangir
- Recruiting
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada, 89144
Site Public Contact, 702-384-0013, research@sncrf.org
Khawaja S. Jahangir
- Recruiting
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada, 89144
Site Public Contact, 702-384-0013, research@sncrf.org
Khawaja S. Jahangir
- Recruiting
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144
Site Public Contact, 702-384-0013, research@sncrf.org
Khawaja S. Jahangir
- Recruiting
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89148
Site Public Contact, 702-384-0013, research@sncrf.org
Khawaja S. Jahangir
- Recruiting
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, 89169
Site Public Contact, 702-384-0013, research@sncrf.org
Khawaja S. Jahangir
- Recruiting
Northside Hospital - Gwinnett
Lawrenceville, Georgia, 30046
Site Public Contact, 404-303-3355, Clinical.trials@northside.com
Aldemar Montero
- Recruiting
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837
Site Public Contact, 570-374-8555, HemonCCTrials@geisinger.edu
Nadia N. Ramdin
- Recruiting
AMG Libertyville - Oncology
Libertyville, Illinois, 60048
Site Public Contact, 630-929-6129, advocateresearch@advocatehealth.com
Thomas J. Saphner
- Recruiting
Condell Memorial Hospital
Libertyville, Illinois, 60048
Site Public Contact, 630-929-6129, advocateresearch@advocatehealth.com
Thomas J. Saphner
- Active, not recruiting
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, 80120
- Active, not recruiting
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, 80124
- Recruiting
PeaceHealth Saint John Medical Center
Longview, Washington, 98632
Site Public Contact, 360-514-2016, kmakin-bond@peacehealth.org
Alison K. Conlin
- Recruiting
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Recruiting
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Recruiting
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Recruiting
Marietta Memorial Hospital
Marietta, Ohio, 45750
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- Recruiting
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Dean A. Delmastro
- Recruiting
Ascension Columbia Saint Mary's Hospital Ozaukee
Mequon, Wisconsin, 53097
Site Public Contact, AWRI.Inquiry@Ascension.org
Bradley C. Heraly
- Recruiting
Beebe South Coastal Health Campus
Millville, Delaware, 19967
Site Public Contact, 302-291-6730, research@beebehealthcare.org
Gregory A. Masters
- Recruiting
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Ascension Columbia Saint Mary's Hospital - Milwaukee
Milwaukee, Wisconsin, 53211
Site Public Contact, AWRI.Inquiry@Ascension.org
Bradley C. Heraly
- Recruiting
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Recruiting
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Recruiting
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Dean A. Delmastro
- Recruiting
Monticello Cancer Center
Monticello, Minnesota, 55362
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Recruiting
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
Site Public Contact, 504-842-8084, Elisemarie.curry@ochsner.org
Randi Kihnel
- Recruiting
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Recruiting
New Ulm Medical Center
New Ulm, Minnesota, 56073
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Recruiting
Manhattan Eye Ear and Throat Hospital
New York, New York, 10065
Site Public Contact, 212-434-4460
Vincent P. Vinciguerra
- Recruiting
Lenox Hill Hospital
New York, New York, 10075
Site Public Contact, 516-734-8896
Vincent P. Vinciguerra
- Recruiting
Helen F Graham Cancer Center
Newark, Delaware, 19713
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Providence Newberg Medical Center
Newberg, Oregon, 97132
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Alison K. Conlin
- Recruiting
Carle BroMenn Medical Center
Normal, Illinois, 61761
Site Public Contact, 800-446-5532, Research@Carle.com
Priyank P. Patel
- Recruiting
Carle Cancer Institute Normal
Normal, Illinois, 61761
Site Public Contact, 800-446-5532, Research@Carle.com
Priyank P. Patel
- Recruiting
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699
Site Public Contact, 800-323-8622
Thomas J. Saphner
- Recruiting
Advocate Outpatient Center - Oak Lawn
Oak Lawn, Illinois, 60453
Site Public Contact, ncorp@aah.org
Thomas J. Saphner
- Recruiting
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Alison K. Conlin
- Recruiting
Lake Regional Hospital
Osage Beach, Missouri, 65065
Site Public Contact, 573-302-2768, clinicaltrials@lakeregional.com
Jay W. Carlson
- Recruiting
Ascension Mercy Hospital
Oshkosh, Wisconsin, 54904
Site Public Contact, AWRI.inquiry@ascension.org
Bradley C. Heraly
- Recruiting
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
Site Public Contact, 847-384-3621
Thomas J. Saphner
- Recruiting
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Methodist Medical Center of Illinois
Peoria, Illinois, 61636
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Illinois CancerCare-Peru
Peru, Illinois, 61354
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Valley Radiation Oncology
Peru, Illinois, 61354
Site Public Contact, 815-664-4141
Bryan A. Faller
- Recruiting
Providence Portland Medical Center
Portland, Oregon, 97213
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Alison K. Conlin
- Recruiting
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Alison K. Conlin
- Recruiting
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Fairview Northland Medical Center
Princeton, Minnesota, 55371
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Recruiting
Ascension All Saints Hospital
Racine, Wisconsin, 53405
Site Public Contact, AWRI.Inquiry@Ascension.org
Bradley C. Heraly
- Recruiting
Aurora Cancer Care-Racine
Racine, Wisconsin, 53406
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Beebe Health Campus
Rehoboth Beach, Delaware, 19971
Site Public Contact, 302-291-6730, research@beebehealthcare.org
Gregory A. Masters
- Recruiting
Renown Regional Medical Center
Reno, Nevada, 89502
Site Public Contact, 702-384-0013, research@sncrf.org
Khawaja S. Jahangir
- Recruiting
Valley Medical Center
Renton, Washington, 98055
Site Public Contact, 425-228-3440, research@valleymed.org
Khawaja S. Jahangir
- Recruiting
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Dean A. Delmastro
- Active, not recruiting
Reid Health
Richmond, Indiana, 47374
- Recruiting
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Recruiting
Wilmot Cancer Institute Radiation Oncology at Greece
Rochester, New York, 14606
Site Public Contact, 585-758-7877
Po-Ju Lin
- Recruiting
Highland Hospital
Rochester, New York, 14620
Site Public Contact, 585-341-8113
Po-Ju Lin
- Recruiting
Pluta Cancer Center
Rochester, New York, 14623
Site Public Contact, 888-823-5923, ctsucontact@westat.com
Po-Ju Lin
- Recruiting
University of Rochester
Rochester, New York, 14642
Site Public Contact, 585-275-5830
Po-Ju Lin
- Recruiting
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Recruiting
Regions Hospital
Saint Paul, Minnesota, 55101
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Recruiting
United Hospital
Saint Paul, Minnesota, 55102
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Recruiting
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670
Site Public Contact, 314-996-5569
Bryan A. Faller
- Recruiting
Memorial Health University Medical Center
Savannah, Georgia, 31404
Site Public Contact, 912-350-7887, Lorraine.OHara@hcahealthcare.com
William E. Burak
- Recruiting
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405
Site Public Contact, 912-819-5704, underberga@sjchs.org
Mark A. Taylor
- Recruiting
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Recruiting
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
VCU Community Memorial Health Center
South Hill, Virginia, 23970
Site Public Contact, nemer.elmouallem@vcuhealth.org
Masey M. Ross
- Recruiting
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org
Michael Humeniuk
- Recruiting
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Site Public Contact, 217-545-7929
Bryan A. Faller
- Recruiting
Springfield Clinic
Springfield, Illinois, 62702
Site Public Contact, 800-444-7541
Bryan A. Faller
- Recruiting
Springfield Memorial Hospital
Springfield, Illinois, 62781
Site Public Contact, 217-528-7541, pallante.beth@mhsil.com
Bryan A. Faller
- Recruiting
Mercy Hospital Springfield
Springfield, Missouri, 65804
Site Public Contact, 417-269-4520
Jay W. Carlson
- Recruiting
Mercy Hospital South
St Louis, Missouri, 63128
Site Public Contact, 314-525-6042, Danielle.Werle@mercy.net
Jay W. Carlson
- Recruiting
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Site Public Contact, 314-996-5569
Bryan A. Faller
- Recruiting
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Dean A. Delmastro
- Recruiting
Lakeview Hospital
Stillwater, Minnesota, 55082
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Recruiting
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495
Site Public Contact, 920-433-8889, wi_research_admin@hshs.org
Brian L. Burnette
- Recruiting
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080
Site Public Contact, 314-996-5569
Bryan A. Faller
- Recruiting
Aurora Medical Center in Summit
Summit, Wisconsin, 53066
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, 63127
Site Public Contact, 314-996-5569
Bryan A. Faller
- Active, not recruiting
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado, 80260
- Recruiting
Tift Regional Medical Center
Tifton, Georgia, 31794
Site Public Contact, 800-648-1935
Apurva N. Shah
- Active, not recruiting
Dayton Physicians LLC - Troy
Troy, Ohio, 45373
- Recruiting
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
SMC Center for Hematology Oncology Union
Union, South Carolina, 29379
Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org
Michael Humeniuk
- Recruiting
Carle Cancer Center
Urbana, Illinois, 61801
Site Public Contact, 800-446-5532, Research@carle.com
Priyank P. Patel
- Recruiting
South Georgia Medical Center/Pearlman Cancer Center
Valdosta, Georgia, 31602
Site Public Contact, 229-259-4628, maryann.heddon@sgmc.org
Samuel N. Ofori
- Recruiting
PeaceHealth Southwest Medical Center
Vancouver, Washington, 98664
Site Public Contact, 360-514-3940, kmakin-bond@peacehealth.org
Alison K. Conlin
- Recruiting
Ridgeview Medical Center
Waconia, Minnesota, 55387
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Active, not recruiting
Saint Joseph Warren Hospital
Warren, Ohio, 44484
- Recruiting
Illinois CancerCare - Washington
Washington, Illinois, 61571
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Site Public Contact, 202-444-2223
Marcus S. Noel
- Recruiting
Ascension Medical Group Southeast Wisconsin - Mayfair Road
Wauwatosa, Wisconsin, 53226
Site Public Contact, AWRI.Inquiry@Ascension.org
Bradley C. Heraly
- Recruiting
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Wilmot Cancer Institute at Webster
Webster, New York, 14580
Site Public Contact, WCICTOresearch@urmc.rochester.edu
Po-Ju Lin
- Recruiting
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Dean A. Delmastro
- Recruiting
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711
Site Public Contact, 570-271-5251, HemonCCTrials@geisinger.edu
Nadia N. Ramdin
- Recruiting
Rice Memorial Hospital
Willmar, Minnesota, 56201
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Recruiting
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, 19801
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Shenandoah Oncology PC
Winchester, Virginia, 22601
Site Public Contact, 540-662-1108, William.Houck@usoncology.com
Masey M. Ross
- Recruiting
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Recruiting
Fairview Lakes Medical Center
Wyoming, Minnesota, 55092
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Active, not recruiting
Saint Elizabeth Youngstown Hospital
Youngstown, Ohio, 44501
About this study
Official title: Longitudinal Observational Trial to Uncover Subtypes of Cancer Cachexia
This study evaluates cancer-related weight and muscle mass loss, symptoms, and physical function (cachexia) in patients undergoing treatment for colorectal, lung, or pancreatic cancer that cannot be removed by surgery (unresectable) or is stage IV. Patients with these cancer types are at risk for developing cancer cachexia (CC), which is defined as weight loss, muscle loss, and fat loss due to cancer. CC has been associated with reduced physical performance, impaired quality of life, and poorer survival. Many studies that have evaluated treatments for cancer-related weight and muscle loss have aimed to treat all patients with weight loss exactly the same and, unfortunately, have not been successful. Like different cancer types, weight and muscle loss related to cancer may have different causes in different individuals and the best treatment strategy for this condition may not be a one-size-fits-all approach. Information gathered from this study may help researchers develop new diagnostic criteria for CC and design better treatments and clinical trials for cancer-related weight and muscle loss in the future to improve the quality of life in patients with advanced colorectal, lung, or pancreatic cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- To identify multiple distinct diagnostic subtypes within the syndrome of CC as defined by host characteristics (e.g. cachexia symptoms, physical activity, physical function, blood biomarkers including hemoglobin and albumin, and body composition) at baseline and change in these factors over time in patients with cancer at high risk for CC.
SECONDARY OBJECTIVES:
- To determine the association of each CC phenotype with overall survival. II. To validate CC diagnostic phenotypes developed in a separate, independent cachexia observational study performed by our collaborators at Kaiser Permanente.
III. To collect human samples of blood, tumor tissue, and medical images and build a large, comprehensive CC database clinically annotated with cancer-related outcomes, cachexia symptoms, and physical function data.
EXPLORATORY OBJECTIVE:
- To evaluate for tumor-derived factors contributing to CC by determining the association between interleukin-6 (IL-6) expression in tumor and IL-6 and CC chemokine ligand 2 (CCL2) levels in the blood in patients with CC.
OUTLINE: This is an observational study.
Patients complete surveys over 30 minutes, undergo physical function tests over 30 minutes, undergo collection of blood and archived tumor samples, and wear actigraph over 24 hours for 7 days to record daily sleep and exercise activity at baseline and 3-month follow-up. Additionally, patients undergo standard of care computed tomography (CT) or positron emission tomography (PET)/CT scans throughout the study and patients' medical records are also reviewed at baseline, 3-month and 1-year follow-up.
- Conditions
- Advanced Colorectal Carcinoma, Advanced Lung Non-Small Cell Carcinoma, Advanced Pancreatic Adenocarcinoma, Stage IV Colorectal Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8
- Being tested
- Biospecimen Collection, Computed Tomography, Electronic Health Record Review, Medical Device Usage and Evaluation, Physical Performance Testing
- Medical subject headings
- Colorectal Neoplasms, Lung Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of blood and archived tumor samples
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT or PET/CT scan
Electronic Health Record ReviewOther
Medical records reviewed
Medical Device Usage and EvaluationOther
Wear actigraph
Physical Performance TestingOther
Also called Physical Fitness Testing, Physical Function Testing
Undergo physical function tests
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET/CT scan
Survey AdministrationOther
Complete surveys
| Study group | Role | What they receive |
|---|---|---|
| Observational (survey, function tests, biospecimen, actigraph) | Patients complete surveys over 30 minutes, undergo physical function tests over 30 minutes, undergo collection of blood and archived tumor samples, and wear actigraph over 24 hours for 7 days to record daily sleep and exercise activity at baseline and 3-month follow-up. Additionally, patients undergo standard of care CT or PET/CT scans throughout the study and patients' medical records are also reviewed at baseline, 3-month and 1-year follow-up. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Electronic Health Record Review; Other: Medical Device Usage and Evaluation; Other: Physical Performance Testing; Procedure: Positron Emission Tomography; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of multiple distinct diagnostic subtypes within the syndrome of cancer cachexia (CC)
Defined by host characteristics (e.g. cachexia symptoms, physical activity, physical function, blood biomarkers including hemoglobin and albumin, and body composition) at baseline and change in these factors over time in patients with cancer at high risk for CC. First, will examine the distributions of each variable and assess the need for using transformations to achieve normality for continuous variables (log transformation, quartiles, or clinically important thresholds), collapsing similar variables into single categories, and excluding conditions that are too rare (< 1% of the cohort). Next, will assess statistical correlations using the Jaccard similarity metric for binary variables and the Pearson or Spearman correlation for continuous variables to determine highly correlated variables that may provide redundant information.
Measured: Baseline through study completion, assessed up to 1 year follow up
Secondary outcomes (2)
Association of each CC phenotype (clusters) with overall survival
Will be assessed in the Cox regression model. Will estimate the bivariate association where the only independent variables will be the indicators for the cluster membership. Will report the hazard ratio for the association of each CC phenotype, specifying the lowest-risk cluster as the reference. Will assess the influence of selected factors (e.g., age, performance status, and other known prognostic factors) on the association of the cluster with survival by adding the factor to the model as a covariate and keeping those that resulted in 10% or more change in any regression coefficients for cluster membership. Will assess if the association of clusters with survival varies by specific subgroups (e.g., older versus younger age, gender, and cancer type). Will assess the statistical significance interaction of the subgroup with the cluster membership by maximum likelihood test and evaluate the regression coefficients for clusters in each subgroup comparing the direction and magnitude.
Measured: Days from registration (day 0) to death (the event) or the last contact (censored), assessed up to 1 year follow up
Validation of CC diagnostic phenotypes developed in a separate, independent cachexia observational study performed by collaborators at Kaiser Permanente
Study participants will be categorized into the Kaiser Permanente Northern California (KPNC)-derived CC phenotype groups. Will use the final latent class analysis model fit in the KPNC data to compute the posterior probabilities of membership in each latent class for each individual National Cancer Institute Community Oncology Research Program (NCORP) participant based on his/her individual data. Will compare cluster prevalence in each cohort as well as the distributions of the variables used to determine each cluster to investigate patterns of commonality and dissimilarity across the contributing variables. Validation will be determined by fitting University of Rochester Cancer Center (URCC) NCORP participants in KPNC-derived clusters and evaluating each cluster's association with survival. If the ranking of survival (best to worst) among each cluster in the URCC NCORP dataset mirrors the prognostic ranking of clusters in the KPNC dataset, the clusters will be deemed validated.
Measured: Up to study completion, assessed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start4 Dec 2023
- Primary completion13 Nov 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Richard Dunne, University of Rochester
- Investigators
- Richard F Dunne, Principal investigator, University of Rochester NCORP Research Base
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073431
- Sponsor's protocol ID
- URCC-22063
- Other IDs
- NCI-2023-04268, URCC-22063, URCC-22063, URCC-22063, UG1CA189961
- Acronym
- LOTUS
- Status last verified
- Jan 2026
- First submitted
- 3 Oct 2023
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Observational Trial to Uncover Subtypes of Cancer Cachexia
- ClinicalTrials.gov ID
- NCT06073431
- Acronym / sponsor ID
- LOTUS / URCC-22063
- Conditions
- Advanced Colorectal Carcinoma, Advanced Lung Non-Small Cell Carcinoma, Advanced Pancreatic Adenocarcinoma, Stage IV Colorectal Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 13 Nov 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates cancer-related weight and muscle mass loss, symptoms, and physical function (cachexia) in patients undergoing treatment for colorectal, lung, or pancreatic cancer that cannot be removed by surgery (unresectable) or is stage IV. Patients with these cancer types are at risk for developing cancer cachexia (CC), which is defined as weight loss, muscle loss, and fat loss due to cancer. CC has been associated with reduced physical performance, impaired quality of life, and poorer survival. Many studies that have evaluated treatments for cancer-related weight and muscle loss have aimed to treat all patients with weight loss exactly the same and, unfortunately, have not been successful. Like different cancer types, weight and muscle loss related to cancer may have different causes in different individuals and the best treatment strategy for this condition may not be a one-size-fits-all approach. Information gathered from this study may help researchers develop new diagnostic criteria for CC and design better treatments and clinical trials for cancer-related weight and muscle loss in the future to improve the quality of life in patients with advanced colorectal, lung, or pancreatic cancer.
Detailed description
PRIMARY OBJECTIVE:
- To identify multiple distinct diagnostic subtypes within the syndrome of CC as defined by host characteristics (e.g. cachexia symptoms, physical activity, physical function, blood biomarkers including hemoglobin and albumin, and body composition) at baseline and change in these factors over time in patients with cancer at high risk for CC.
SECONDARY OBJECTIVES:
- To determine the association of each CC phenotype with overall survival. II. To validate CC diagnostic phenotypes developed in a separate, independent cachexia observational study performed by our collaborators at Kaiser Permanente.
III. To collect human samples of blood, tumor tissue, and medical images and build a large, comprehensive CC database clinically annotated with cancer-related outcomes, cachexia symptoms, and physical function data.
EXPLORATORY OBJECTIVE:
- To evaluate for tumor-derived factors contributing to CC by determining the association between interleukin-6 (IL-6) expression in tumor and IL-6 and CC chemokine ligand 2 (CCL2) levels in the blood in patients with CC.
OUTLINE: This is an observational study.
Patients complete surveys over 30 minutes, undergo physical function tests over 30 minutes, undergo collection of blood and archived tumor samples, and wear actigraph over 24 hours for 7 days to record daily sleep and exercise activity at baseline and 3-month follow-up. Additionally, patients undergo standard of care computed tomography (CT) or positron emission tomography (PET)/CT scans throughout the study and patients' medical records are also reviewed at baseline, 3-month and 1-year follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (survey, function tests, biospecimen, actigraph) | – | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Other: Electronic Health Record Review, Other: Medical Device Usage and Evaluation, Other: Physical Performance Testing, Procedure: Positron Emission Tomography, Other: Survey AdministrationPatients complete surveys over 30 minutes, undergo physical function tests over 30 minutes, undergo collection of blood and archived tumor samples, and wear actigraph over 24 hours for 7 days to record daily sleep and exercise activity at baseline and 3-month follow-up. Additionally, patients undergo standard of care CT or PET/CT scans throughout the study and patients' medical records are also reviewed at baseline, 3-month and 1-year follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing treatment for non-small cell lung cancer (NSCLC), pancreatic adenocarcinoma, colorectal cancer.
Key inclusion criteria (7 listed)
- Have a primary diagnosis of unresectable or stage IV 1) non-small cell lung cancer (NSCLC), 2) pancreatic adenocarcinoma, or 3) colorectal cancer
- Plan to start first-line systemic anti-cancer therapy (chemotherapy, immunotherapy, targeted therapy, interventional clinical trial) in the next 6 weeks or has started first-line systemic therapy in the previous 6 weeks.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- Be able to understand, speak and read English
- Be 18 years of age or older
Key exclusion criteria (4 listed)
- Have contraindications to physical function assessments (30-second arm curl, Timed-Up-And-Go test, or 30-second chair-stand test) per the treating provider or their designee
- Have any planned major surgeries within the next 3 months
- Have received chemotherapy or surgery for separate primary cancer within the past 3 years other than early local staged non-melanoma skin cancer
- Be pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo collection of blood and archived tumor samples | Procedure or surgery | Observational (survey, function tests, biospecimen, actigraph) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT or PET/CT scan | Procedure or surgery | Observational (survey, function tests, biospecimen, actigraph) |
| Electronic Health Record ReviewMedical records reviewed | Other | Observational (survey, function tests, biospecimen, actigraph) |
| Medical Device Usage and EvaluationWear actigraph | Other | Observational (survey, function tests, biospecimen, actigraph) |
| Physical Performance TestingAlso: Physical Fitness Testing, Physical Function TestingUndergo physical function tests | Other | Observational (survey, function tests, biospecimen, actigraph) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)Undergo PET/CT scan | Procedure or surgery | Observational (survey, function tests, biospecimen, actigraph) |
| Survey AdministrationComplete surveys | Other | Observational (survey, function tests, biospecimen, actigraph) |
Primary outcome
Identification of multiple distinct diagnostic subtypes within the syndrome of cancer cachexia (CC)
Time frame: Baseline through study completion, assessed up to 1 year follow up
Defined by host characteristics (e.g. cachexia symptoms, physical activity, physical function, blood biomarkers including hemoglobin and albumin, and body composition) at baseline and change in these factors over time in patients with cancer at high risk for CC. First, will examine the distributions of each variable and assess the need for using transformations to achieve normality for continuous variables (log transformation, quartiles, or clinically important thresholds), collapsing similar variables into single categories, and excluding conditions that are too rare (< 1% of the cohort). Next, will assess statistical correlations using the Jaccard similarity metric for binary variables and the Pearson or Spearman correlation for continuous variables to determine highly correlated variables that may provide redundant information.
2 secondary outcomes
Association of each CC phenotype (clusters) with overall survival
Time frame: Days from registration (day 0) to death (the event) or the last contact (censored), assessed up to 1 year follow up
Validation of CC diagnostic phenotypes developed in a separate, independent cachexia observational study performed by collaborators at Kaiser Permanente
Time frame: Up to study completion, assessed up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard F Dunne principal investigator
University of Rochester NCORP Research Base
225 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Colorectal Carcinoma and Advanced Lung Non-Small Cell Carcinoma, run by University of Rochester at 225 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 225 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of multiple distinct diagnostic subtypes within the syndrome of cancer cachexia (CC) (time frame: Baseline through study completion, assessed up to 1 year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.