COVID-19 InfectionNCT04387656
NCI COVID-19 in Cancer Patients, NCCAPS Study
An observational study of COVID-19 Infection and Hematopoietic and Lymphatic System Neoplasm, run by National Cancer Institute (NCI) at 932 sites in 3 countries.
Trial summary
This study collects blood samples, medical information, and medical images from patients who are being treated for cancer and have a positive test for SARS CoV-2, the new coronavirus that causes the disease called COVID-19. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19 Infection, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Biospecimen Collection, Data Collection and Quality-of-Life Assessment
- Type of treatment
- Surgery or procedure
- How many people
- 1,877 participants
- Where
- 932 sitesin 3 countries
- Study dates
- 5 Jun 2020to 14 Oct 2027
- Phase
- Observational
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a prior or current cancer diagnosis and with a positive SARS CoV-2 test within 14 days of enrollment
Who may be able to join
- NCCAPS STUDY ELIGIBILITY CRITERIA:
- Patient must have a prior or current cancer diagnosis (e.g., solid tumor or hematologic malignancy) and cancer treatment that fits into one of the three following categories:
- Metastatic (stage IV) solid tumor, any hematologic malignancy, or any central nervous system (CNS) malignancy, and:
- Patient is receiving eligible active treatment (defined as current treatment or treatment within the 6 weeks prior to their first positive SARS-CoV-2 test collection) or is expected to begin receiving treatment within 2 weeks of study enrollment
- Eligible active treatment types are chemotherapy, immunotherapy, monoclonal antibody therapy (e.g., rituximab, trastuzumab, cetuximab), targeted therapy (e.g., BRAF/MEK inhibitor, EGF-R inhibitor), endocrine therapy, radiation therapy, or targeted radionuclide therapy; OR
- Non-metastatic (Stage I-III) solid tumor and:
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- Patient is receiving eligible active treatment (defined as current treatment or treatment within past 6 weeks prior to their first positive SARS-CoV-2 test collection) or is expected to begin receiving treatment within 2 weeks of study enrollment
- Eligible active treatment types for non-metastatic solid tumor patients are intravenous chemotherapy, immunotherapy, targeted therapy, radiation therapy, targeted radionuclide therapy, or monoclonal antibody therapy (except as noted below)
- HER2-targeted therapy (trastuzumab, pertuzumab, neratinib, ado-trastuzumab) that is not accompanied by chemotherapy is NOT considered an eligible active treatment
- Patients on endocrine therapy alone are not eligible; OR
- Prior or current transplant for the treatment of cancer:
- Patient has received an allogenic stem cell/bone marrow transplant or chimeric antigen receptor (CAR)-T cell or other modified cellular therapy at any time; or
- Patient is currently receiving treatment or prophylaxis for graft versus (vs.) host disease; or
- Patient has received an autologous stem cell/bone marrow transplant within the past 2 years
- Patient must have documented positive viral test result for SARS-CoV-2
- For patients 18 years of age or older, the specimen collection for the patient's FIRST positive test must have occurred no earlier than 14 days prior to enrollment
- For patients under 18 years of age, the specimen collection for the patient's first positive test must have occurred after January 31, 2020
- The viral test can be either a nucleic acid (polymerase chain reaction [PCR]) test or an antigen test. Serological or antibody tests are not allowed
- Any specimen source (e.g., nasopharyngeal swab, oropharyngeal swab, etc.) is allowable for the viral SARS-CoV-2 test
- Patients with prior negative viral SARS-CoV-2 test(s) are eligible if they are being tested again
- The SARS-CoV-2 test must be a validated diagnostic assay performed in accordance with the most recent guidance issued by the Food and Drug administration (FDA) in the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. This policy is available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-coronavirus-disease-2019-tests-during-public-health-emergency-revised
- Human immunodeficiency virus (HIV)-infected patients are eligible
- Patients with CNS metastases are eligible
- Co-enrollment on other clinical trials (for cancer or for COVID-19) is allowed
- PEDIATRIC COVNET COHORT ELIGIBILITY CRITERIA:
- Patients should only be enrolled in the pediatric COVNET cohort if they are not eligible for the main NCCAPS Study cohort or decline to participate in the main study
- Patient must be < 18 years of age
- Patient must have a positive SARS-CoV-2 viral test after January 31, 2020
- Patient must have a current or prior diagnosis of cancer. Active cancer treatment is not required
- Note: Patients who enroll on Pediatric COVNET cohort will not be followed longitudinally; study data collection involves only a single questionnaire and research blood collection. A separate consent document is provided for the Pediatric COVNET cohort
Who cannot join
None listed.
Trial locations and contacts
932 sites in 3 countries.
304 sites in 3 countries
United States300 sites
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520
Summa Health System - Akron Campus
Akron, Ohio, 44304
Cleveland Clinic Akron General
Akron, Ohio, 44307
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
Phoebe Putney Memorial Hospital
Albany, Georgia, 31701
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
OSF Saint Anthony's Health Center
Alton, Illinois, 62002
Community Hospital of Anaconda
Anaconda, Montana, 59711
Kaiser Permanente-Anaheim
Anaheim, California, 92806
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508
Anchorage Radiation Therapy Center
Anchorage, Alaska, 99504
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
Alaska Women's Cancer Care
Anchorage, Alaska, 99508
Anchorage Oncology Centre
Anchorage, Alaska, 99508
Katmai Oncology Group
Anchorage, Alaska, 99508
Providence Alaska Medical Center
Anchorage, Alaska, 99508
AnMed Health Cancer Center
Anderson, South Carolina, 29621
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Aspirus Cancer Care-Antigo-Volm Cancer Center
Antigo, Wisconsin, 54409
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, 94531
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton
Appleton, Wisconsin, 54915
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, 93420
PCR Oncology
Arroyo Grande, California, 93420
University Cancer and Blood Center LLC
Athens, Georgia, 30607
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, 30329
Hematology Oncology Associates of Central New York-Auburn
Auburn, New York, 13021
Augusta Oncology Associates PC-D'Antignac
Augusta, Georgia, 30901
Augusta Oncology Associates PC-Wheeler
Augusta, Georgia, 30909
Augusta University Medical Center
Augusta, Georgia, 30912
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012
The Medical Center of Aurora
Aurora, Colorado, 80012
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, 80045
Rush-Copley Medical Center
Aurora, Illinois, 60504
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180
Saint Alphonsus Cancer Care Center-Baker City
Baker City, Oregon, 97814
Kaiser Permanente-Baldwin Park
Baldwin Park, California, 91706
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri, 63011
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
Mercy Medical Center
Baltimore, Maryland, 21202
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Kaiser Permanente-Woodlawn Medical Center
Baltimore, Maryland, 21244
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
Eastern Maine Medical Center
Bangor, Maine, 04401
CommonSpirit Saint Joseph Hospital - Bardstown
Bardstown, Kentucky, 40004
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, 70805
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, 70808
Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana, 70809
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
Medical Center of Baton Rouge
Baton Rouge, Louisiana, 70816
Louisiana Hematology Oncology Associates
Baton Rouge, Louisiana, 70817
Our Lady of the Lake Medical Oncology
Baton Rouge, Louisiana, 70817
Woman's Hospital
Baton Rouge, Louisiana, 70817
Ochsner High Grove
Baton Rouge, Louisiana, 70836
Bronson Battle Creek
Battle Creek, Michigan, 49017
McLaren Cancer Institute-Bay City
Bay City, Michigan, 48706
Baptist Hospitals of Southeast Texas Cancer Center
Beaumont, Texas, 77701
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431
MaineHealth Waldo Hospital
Belfast, Maine, 04915
Nebraska Medicine-Bellevue
Bellevue, Nebraska, 68123
Overlake Medical Center
Bellevue, Washington, 98004
Kaiser Permanente-Bellflower
Bellflower, California, 90706
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Saint Charles Health System
Bend, Oregon, 97701
ThedaCare Cancer Care - Berlin
Berlin, Wisconsin, 54923
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017
Beverly Hospital
Beverly, Massachusetts, 01915
MaineHealth Maine Medical Center - Biddeford
Biddeford, Maine, 04005
Southern Maine Health Center/Biddeford Medical Center
Biddeford, Maine, 04005
Billings Clinic Cancer Center
Billings, Montana, 59101
Saint Vincent Healthcare
Billings, Montana, 59101
Saint Vincent Frontier Cancer Center
Billings, Montana, 59102
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
Veterans Administration Medical Center - Birmingham
Birmingham, Alabama, 35233
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Saint Joseph's/Candler - Bluffton Campus
Bluffton, South Carolina, 29910
Saint Elizabeth Boardman Hospital
Boardman, Ohio, 44512
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613
Tufts Medical Center
Boston, Massachusetts, 02111
Boulder Community Foothills Hospital
Boulder, Colorado, 80303
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Florida Cancer Specialists - Bradenton Cancer Center
Bradenton, Florida, 34205
Cox Cancer Center Branson
Branson, Missouri, 65616
Northeast Georgia Medical Center Braselton
Braselton, Georgia, 30517
Lafayette Family Cancer Center-EMMC
Brewer, Maine, 04412
Ocean University Medical Center
Brick, New Jersey, 08724
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114
University of Michigan - Brighton Center for Specialty Care
Brighton, Michigan, 48116
Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield
Brookfield, Wisconsin, 53045
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, 48183
Saint Joseph Regional Cancer Center
Bryan, Texas, 77802
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
Roswell Park Cancer Institute
Buffalo, New York, 14263
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505
Saint Anne Hospital
Burien, Washington, 98166
Kaiser Permanente-Burke Medical Center
Burke, Virginia, 22015
Lahey Clinic
Burlington, Massachusetts, 01805
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105
Fairview Ridges Hospital
Burnsville, Minnesota, 55337
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
Loyola Center for Health at Burr Ridge
Burr Ridge, Illinois, 60527
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
Cambridge Medical Center
Cambridge, Minnesota, 55008
Cooper Hospital University Medical Center
Camden, New Jersey, 08103
Hematology Oncology Associates of CNY at Camillus
Camillus, New York, 13031
Illinois CancerCare-Canton
Canton, Illinois, 61520
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
Trinity Health Medical Center - Canton
Canton, Michigan, 48188
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, 63703
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902
IU Health North Hospital
Carmel, Indiana, 46032
Caro Cancer Center
Caro, Michigan, 48723
Saint Anthony Regional Hospital
Carroll, Iowa, 51401
Carson Tahoe Regional Medical Center
Carson City, Nevada, 89703
SIH Cancer Institute
Carterville, Illinois, 62918
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, 52402
Mercy Hospital
Cedar Rapids, Iowa, 52403
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado, 80112
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459
Miami Valley Hospital South
Centerville, Ohio, 45459
Centralia Oncology Clinic
Centralia, Illinois, 62801
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Medical University of South Carolina
Charleston, South Carolina, 29425
Vandalia Health/CAMC Institute for Academic Medicine
Charleston, West Virginia, 25304
Chelsea Hospital
Chelsea, Michigan, 48118
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Cheyenne Regional Medical Center-West
Cheyenne, Wyoming, 82001
Lurie Children's Hospital-Chicago
Chicago, Illinois, 60611
Northwestern University
Chicago, Illinois, 60611
University of Illinois
Chicago, Illinois, 60612
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Enloe Medical Center
Chico, California, 95926
Adventist Health Cancer Care Center Chico
Chico, California, 95973
Adena Regional Medical Center
Chillicothe, Ohio, 45601
Ascension Calumet Hospital-Chilton
Chilton, Wisconsin, 53014
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, 54729
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236
Bethesda North Hospital
Cincinnati, Ohio, 45242
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, 45247
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, 45255
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, 48346
McLaren Cancer Institute-Clarkston
Clarkston, Michigan, 48346
Newland Medical Associates-Clarkston
Clarkston, Michigan, 48346
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325
Billings Clinic-Cody
Cody, Wyoming, 82414
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, 38017
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907
Saint Francis Cancer Center
Colorado Springs, Colorado, 80923
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri, 65212
Prisma Health Richland Hospital
Columbia, South Carolina, 29203
Prisma Health Baptist Hospital
Columbia, South Carolina, 29220
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, 39705
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Mount Carmel East Hospital
Columbus, Ohio, 43213
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214
Riverside Methodist Hospital
Columbus, Ohio, 43214
Grant Medical Center
Columbus, Ohio, 43215
The Mark H Zangmeister Center
Columbus, Ohio, 43219
Mount Carmel Health Center West
Columbus, Ohio, 43222
Doctors Hospital
Columbus, Ohio, 43228
Memorial Sloan Kettering Commack
Commack, New York, 11725
Mercy Hospital
Coon Rapids, Minnesota, 55433
Bay Area Hospital
Coos Bay, Oregon, 97420
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, 40701
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
UC Irvine Health Cancer Center-Newport
Costa Mesa, California, 92627
Alegent Health Mercy Hospital
Council Bluffs, Iowa, 51503
Heartland Oncology and Hematology LLP
Council Bluffs, Iowa, 51503
Methodist Jennie Edmundson Hospital
Council Bluffs, Iowa, 51503
Mary Bird Perkins Cancer Center - Covington
Covington, Louisiana, 70433
Northshore Oncology Associates-Covington
Covington, Louisiana, 70433
Ochsner Hematology Oncology North Shore - Covington (West Region)
Covington, Louisiana, 70433
Women's Cancer Care-Covington
Covington, Louisiana, 70433
Greater Regional Medical Center
Creston, Iowa, 50801
Aurora Saint Luke's South Shore
Cudahy, Wisconsin, 53110
Parkland Memorial Hospital
Dallas, Texas, 75235
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Carle at The Riverfront
Danville, Illinois, 61832
Geisinger Medical Center
Danville, Pennsylvania, 17822
Miami Valley Hospital
Dayton, Ohio, 45409
Dayton Physician LLC - Englewood
Dayton, Ohio, 45415
Miami Valley Hospital North
Dayton, Ohio, 45415
Corewell Health Dearborn Hospital
Dearborn, Michigan, 48124
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, 48126
Atlanta VA Medical Center
Decatur, Georgia, 30033
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Decatur Memorial Hospital
Decatur, Illinois, 62526
Broward Health North
Deerfield Beach, Florida, 33064
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015
Grady Memorial Hospital
Delaware, Ohio, 43015
Cancer Center of Colorado at Sloan's Lake
Denver, Colorado, 80204
Kaiser Permanente-Franklin
Denver, Colorado, 80205
National Jewish Health-Main Campus
Denver, Colorado, 80206
The Women's Imaging Center
Denver, Colorado, 80209
AdventHealth Porter
Denver, Colorado, 80210
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, 80218
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado, 80218
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, 80220
Rose Medical Center
Denver, Colorado, 80220
Western Surgical Care
Denver, Colorado, 80220
Blank Children's Hospital
Des Moines, Iowa, 50309
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309
Broadlawns Medical Center
Des Moines, Iowa, 50314
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, 50316
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
Henry Ford Hospital
Detroit, Michigan, 48202
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
Wentworth-Douglass Hospital
Dover, New Hampshire, 03820
Doylestown Hospital
Doylestown, Pennsylvania, 18901
Kaiser Permanente Dublin
Dublin, California, 94568
Dublin Methodist Hospital
Dublin, Ohio, 43016
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, 18512
CommonSpirit Cancer Center Mercy
Durango, Colorado, 81301
Mercy Medical Center
Durango, Colorado, 81301
Durham VA Medical Center
Durham, North Carolina, 27705
Duke University Medical Center
Durham, North Carolina, 27710
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640
Henry Ford River District Hospital
East China Township, Michigan, 48054
Michigan State University
East Lansing, Michigan, 48823
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, 13057
HSHS Sacred Heart Hospital
Eau Claire, Wisconsin, 54701
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, 54701
Fairview Southdale Hospital
Edina, Minnesota, 55435
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Crossroads Cancer Center
Effingham, Illinois, 62401
Trinitas Hospital and Comprehensive Cancer Center - Williamson Street Campus
Elizabeth, New Jersey, 07207
Elmhurst Hospital Center
Elmhurst, New York, 11373
Walter Knox Memorial Hospital
Emmett, Idaho, 83617
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, 80113
Rocky Mountain Cancer Centers - Swedish
Englewood, Colorado, 80113
Swedish Medical Center
Englewood, Colorado, 80113
Saint Elizabeth Hospital
Enumclaw, Washington, 98022
Ephrata Cancer Center
Ephrata, Pennsylvania, 17522
Saint Vincent Hospital
Erie, Pennsylvania, 16544
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Providence Regional Cancer Partnership
Everett, Washington, 98201
Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701
University of Kansas Clinical Research Center
Fairway, Kansas, 66205
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Parkland Health Center - Farmington
Farmington, Missouri, 63640
Farmington Health Center
Farmington, Utah, 84025
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334
Corewell Health Farmington Hills Hospital
Farmington Hills, Michigan, 48336
Saint Francis Hospital
Federal Way, Washington, 98003
Armes Family Cancer Center
Findlay, Ohio, 45840
Blanchard Valley Hospital
Findlay, Ohio, 45840
Orion Cancer Care
Findlay, Ohio, 45840
Augusta Health Center for Cancer and Blood Disorders
Fishersville, Virginia, 22939
Hunterdon Medical Center
Flemington, New Jersey, 08822
Cancer Hematology Centers - Flint
Flint, Michigan, 48503
Genesee Hematology Oncology PC
Flint, Michigan, 48503
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Hurley Medical Center
Flint, Michigan, 48503
McLaren Cancer Institute-Flint
Flint, Michigan, 48532
Singh and Arora Hematology Oncology PC
Flint, Michigan, 48532
Saint Agnes Hospital/Agnesian Cancer Center
Fond du Lac, Wisconsin, 54935
Kaiser Permanente-Fontana
Fontana, California, 92335
UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa, 50501
Canada2 sites
CSSS Champlain-Charles Le Moyne
Greenfield Park, Quebec, J4V 2H1
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
Puerto Rico2 sites
University Pediatric Hospital
San Juan, 00926
Centro Comprensivo de Cancer de UPR
San Juan, 00927
About this study
Official title: NCI COVID-19 in Cancer Patients Study (NCCAPS): A Longitudinal Natural History Study
This study collects blood samples, medical information, and medical images from patients who are being treated for cancer and have a positive test for SARS CoV-2, the new coronavirus that causes the disease called COVID-19. Collecting blood samples, medical information, and medical images may help researchers determine how COVID-19 affects the outcomes of patients undergoing cancer treatment and how having cancer affects COVID-19.
Read the detailed description
PRIMARY OBJECTIVES:
- Characterize patient factors, such as pre-existing comorbidities, cancer type and treatment, and demographic factors, associated with short- and long-term outcomes of coronavirus 2019 (COVID-19), including symptoms, severity, and fatality, in adult and pediatric cancer patients undergoing treatment.
II. Describe cancer treatment modifications made in response to COVID-19 in adult and pediatric patients, including dose adjustments, changes in symptom management, or temporary or permanent cessation.
III. Evaluate the association of COVID-19 with cancer outcomes in adult patient subgroups defined by clinico-pathologic characteristics and in pediatric patients.
EXPLORATORY CORRELATIVE OBJECTIVES:
- Study the immune response to COVID-19 in patients with cancer by assessing cytokines by Olink profiling and the cellular compartment of the immune system using mass cytometry (CyTOF).
II. Describe coagulation abnormalities in COVID-19 cancer patients. III. Describe the development of severe acute respiratory syndrome (SARS) coronavirus 2 (SARS CoV-2) antibodies and neutralizing antibodies in cancer patients.
IV. Investigate both common and rare genetic variants associated with differences in disease outcome using a case-case design to increase understanding of COVID-19 disease in cancer patients using large-scale genome-wide association studies and whole genome sequencing.
- Characterize the development and longevity of vaccine-induced immunity using serology (ligand-binding assays) and neutralizing antibodies.
VI. Collect and bank research blood specimens and radiological images for future research.
PATIENT-REPORTED HEALTH-RELATED QUALITY OF LIFE OBJECTIVES:
- Describe patient-reported short-and long-term physical health, defined as a composite of physical function, pain interference and intensity, and ability to participate in social roles and activities, as measured by the Patient Reported Outcomes Measurement Information System (PROMIS)-29 version (v)2.0 profile in adult cancer patients diagnosed with COVID-19. (Primary) II. Describe patient-reported short-and long-term symptoms (anxiety, depression, and dyspnea) and function (cognitive function and social isolation) in adult cancer patients diagnosed with COVID-19. (Secondary) III. Assess how patient-reported physical health (primary objective) and symptoms and function (secondary objective) in adult cancer patients vary by COVID-19 symptom burden, cancer type, cancer treatment, comorbidities, tobacco use, body mass index, and demographic characteristics. (Exploratory)
PEDIATRIC COVNET COHORT OBJECTIVE (FOR PATIENTS < 18 YEARS OLD):
- Investigate both common and rare variants associated with differences in disease outcome using a case-case design for children and adolescents, < 18 years old to increase understanding of COVID-19 in pediatric cancer patients.
OUTLINE:
Patients undergo collection of medical information about COVID-19 symptoms, treatments/cancer treatments and outcomes, and results from laboratory tests and imaging scans performed as part of routine care for up to 2 years. Patients also undergo collection of blood samples at the same times they receive routine bloodwork up to 8 times for adults and up to 5 times for children. Patients who are hospitalized for COVID-19 undergo collection of blood samples at up to 6 additional times for adults and up to 3 additional times for children. Adult patients also complete quality of life questionnaire.
- Conditions
- COVID-19 Infection, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm
- Being tested
- Biospecimen Collection, Data Collection, Quality-of-Life Assessment, Questionnaire Administration
- Keywords
- COVID-19
- Medical subject headings
- COVID-19, Neoplasm Metastasis
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, Sample Collection, Specimen Collection
Undergo collection of blood samples
Data CollectionOther
Also called Data Capture
Undergo collection of medical information and imaging
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Complete quality of life questionnaires
Questionnaire AdministrationOther
Complete quality of life questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Observational Cohort (data collection, biospecimen collection) | Patients undergo collection of medical information about COVID-19 symptoms, treatments/cancer treatments and outcomes, and results from laboratory tests and imaging scans performed as part of routine care for up to 2 years. Patients also undergo collection of blood samples at the same times they receive routine bloodwork up to 8 times for adults and up to 5 times for children. Patients who are hospitalized for COVID-19 undergo collection of blood samples at up to 6 additional times for adults and up to 3 additional times for children. Adult patients also complete quality of life questionnaire. Receives: Procedure: Biospecimen Collection; Other: Data Collection; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient variables (factors) associated with severe acute respiratory syndrome (SARS) coronavirus 2 (COVID-19) severity
Distinguish the likelihood of severe COVID19 (for example, requiring hospitalization, requiring intensive care unit [ICU] treatment or requiring a ventilator) and death due to COVID-19 for patients with versus without the factor. Among subgroups of at least 50 patients, evaluate using chi-square tests as well as death and hospitalization rates.
Measured: Up to 2 years
Effects of COVID-19 on cancer therapy and association with clinical outcomes
Describe the degree to which COVID-19 interrupts, delays, or otherwise alters cancer treatment for pediatric patients and subgroups of adult patients defined by cancer type and/or treatment modality. Describe the association between changes in cancer therapy and clinical outcomes. Evaluate association of COVID-19 with outcome by comparison to historical controls in subgroups of at least 50 patients using log rank tests to assess time to survival event.
Measured: Up to 2 years
Physical health (patient-reported health-related quality of life)
Will be measured using items from the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Profile.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start5 Jun 2020
- Primary completion20 Mar 2024
- Study completion14 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Other
- Time perspective
- Other
- Enrolment
- 1,877 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lyndsay N Harris, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387656
- Sponsor's protocol ID
- NCI-2020-02986
- Other IDs
- NCI-2020-02986, NCICOVID, NCICOVID
- Status last verified
- Oct 2026
- First submitted
- 13 May 2020
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.