Acute Myeloid LeukemiaNCT04314401
National Cancer Institute "Cancer Moonshot Biobank"
An observational study of Acute Myeloid Leukemia and Anatomic Stage III Breast Cancer AJCC v8, run by National Cancer Institute (NCI) at 150 sites in 2 countries.
Trial summary
This trial collects multiple tissue and blood samples, along with medical information, from cancer patients. The "Cancer Moonshot Biobank" is a longitudinal study. This means it collects and stores samples and information over time, throughout the course of a patient's cancer treatment. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
- What is being tested?
- Biospecimen Collection, Computed Tomography and Magnetic Resonance Imaging
- Type of treatment
- Surgery or procedure
- How many people
- 1,600 participants
- Where
- 150 sitesin 2 countries
- Study dates
- 11 Nov 2020to 30 Apr 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing treatment for cancer types with commercially available therapies.
Who may be able to join
- Is consistent with OR has been diagnosed with one of the following:
- Colorectal cancer: stage IV
- Non-small cell or small cell lung cancer: stage III/IV
- Prostate cancer: metastatic prostate cancer
- Gastric cancer, not otherwise specified (NOS): stage IV
- Esophageal cancer, NOS: stage IV
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- Adenocarcinoma of gastroesophageal junction: stage IV
- High grade serous ovarian cancer: stage III/IV
- Invasive breast carcinoma: stage III/IV
- Melanoma: stage III/IV
- Acute myeloid leukemia
- Multiple myeloma
- For the purposes of this study,
- Re-staging is allowed
- Having more than one primary cancer is allowed, if the patient is being treated solely for one of the eligible cancers listed above
- Patient should fit in one of the following four clinical scenarios (a-d)
- Undergoing diagnostic workup for one of the diseases listed for which treatment will likely include a new regimen of standard of care therapy OR
- Scheduled to begin treatment with a new regimen of standard of care therapy OR
- Currently progressing on a regimen of standard of care therapy OR
- Currently being treated with a regimen standard of care therapy, without evidence of progression
- Requirements for fresh tissue biospecimen collections at enrollment:
- For clinical scenarios a, b, and c above, freshly collected tumor tissue or bone marrow (BM) aspirate must be submitted at enrollment
- For clinical scenarios a and b, the fresh tissue collection must be prior to starting therapy
- For clinical scenario a, the biospecimen collection must be part of a standard of care medical procedure
- For clinical scenarios b or c, the biospecimen collection may be part of a standard of care medical procedure OR
- The biospecimen collection may be part of a study-specific procedure ("research only biopsy"), when the patient has a tumor amenable to image guided or direct vision biopsy and is willing and able to undergo a tumor biopsy for molecular profiling
- Note: For research-only biopsies, the biopsy must not be associated with a significant risk of severe or major complications or death; the procedure cannot be a mediastinal, laparoscopic, open or endoscopic biopsy; nor can the procedure be a brain biopsy; nor can the patient be under the age of majority as determined by each U.S. state
- Requirements for archival tissue:
- For clinical scenarios a and b above, archival tissue as outlined below must be submitted IF AVAILABLE
- For clinical scenarios c and d above, archival tissue as outlined below is REQUIRED
- Pre-existing archival material (formalin-fixed, paraffin-embedded [FFPE] block, BM aspirate, or unstained slides) that:
- Contains the cancer type for which the participant is enrolled, and
- Was collected no more than 5 years prior to initiation of therapy, and
- Contains at least a surface area of 5 mm^2 and optimal surface area of 25 mm^2 or 3-5 mL cryopreserved bone marrow aspirate to yield 200 million bone marrow mononuclear cells, and
- Contains at least 10% tumor content. 70% tumor content is optimal, and
- No more than 1 line of standard of care systemic therapy was administered from the date of archival material collection to the date of initiation of therapy
- Requirements for blood collection: ALL scenarios require fresh blood collection at enrollment
- Blood collection for clinical scenarios a, b, and c must take place within 1 week of fresh tumor specimen collection
- Blood collection for clinical scenario d must take place within 4 weeks of enrollment, and while patient is on treatment
- Age 13 or older
- Any sex
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
- Ability to understand and willingness to sign an informed consent document. Consent may be provided by a Legally Authorized Representative (LAR) in accordance with 45 CFR 46.102(i)
- NCI PDMR INCLUSION CRITERIA: Patients with CRC with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) status
- NCI PDMR INCLUSION CRITERIA: Patients with CRC who are 40 years old or younger at time of collection irrespective of mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) status
- NCI PDMR INCLUSION CRITERIA: Patients with BRCA that are either
- Any race/ethnicity with hormone receptor positive (ER+PR+, ER+PR-, or ER-PR+)
- African American with triple negative (ER-PR-HER2-)
- NCI PDMR INCLUSION CRITERIA: Patients with lung cancer (LCA), prostate cancer (PCA), gastroesophageal cancer (GEC), ovarian cancer (OV), acute myeloid leukemia (AML), multiple myeloma (MML)
Who cannot join
- Treated with or has already begun treatment with a non-standard of care therapeutic agent (investigational) in an interventional clinical trial
- For the purposes of this study, past enrollment in clinical trials whereby the patient was randomized and treated with standard-of-care anti-cancer treatment (chemotherapy regimen, surgery and radiation therapy) is allowed
- Uncontrolled intercurrent illness that in the physician's assessment would pose undue risk for biopsy
- Use of full dose coumarin-derivative anticoagulants such as warfarin are prohibited. Patients may be switched to low molecular weight (LMW) heparin at physician discretion
- Low molecular weight (LMW) heparin is permitted for prophylactic or therapeutic use
- Factor X inhibitors are permitted
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- Use of anti-platelet drugs are permitted
- Stopping the anticoagulation treatment for biopsy, bone marrow aspirate, or resection should be per site standard operating procedure (SOP)
- NCI PDMR EXCLUSION CRITERIA: Patients with complete response
- NCI PDMR EXCLUSION CRITERIA: Patients with invasive fungal infections
- NCI PDMR EXCLUSION CRITERIA: Patients with active and/or uncontrolled infections or who are still recovering from an infection
- Actively febrile patients with uncertain etiology of febrile episode
- All antibiotics for non-prophylactic treatment of infection should be completed at least 1 week (7 days) prior to collection
- No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics
- NCI PDMR EXCLUSION CRITERIA: Patients with human immunodeficiency virus (HIV), active or chronic hepatitis (i.e. quantifiable hepatitis B virus [HBV]-deoxyribonucleic acid [DNA] and/or positive hepatitis B surface antigen [HbsAg], quantifiable hepatitis C virus [HCV]-ribonucleic acid [RNA]) or known history of HBV/HCV without documented resolution
Trial locations and contacts
150 sites in 2 countries.
150 sites in 2 countries
United States147 sites
McFarland Clinic - Ames
Ames, Iowa, 50010
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
PCR Oncology
Arroyo Grande, California, 93420
Northside Hospital
Atlanta, Georgia, 30342
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield, California, 93301
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri, 63011
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, 70808
MaineHealth Waldo Hospital
Belfast, Maine, 04915
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, 52722
MaineHealth Maine Medical Center - Biddeford
Biddeford, Maine, 04005
Saint Vincent Frontier Cancer Center
Billings, Montana, 59102
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Boca Raton Regional Hospital
Boca Raton, Florida, 33486
Intermountain Health Platte Valley Hospital
Brighton, Colorado, 80601
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114
MaineHealth Cancer Care and IV Therapy - Brunswick
Brunswick, Maine, 04011
Mid Coast Hospital
Brunswick, Maine, 04011
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701
Trinity Health Medical Center - Canton
Canton, Michigan, 48188
Carson Tahoe Regional Medical Center
Carson City, Nevada, 89703
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, 52402
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204
Chelsea Hospital
Chelsea, Michigan, 48118
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
Swedish Covenant Hospital
Chicago, Illinois, 60625
Prisma Health Richland Hospital
Columbia, South Carolina, 29203
Prisma Health Baptist Hospital
Columbia, South Carolina, 29220
MaineHealth LincolnHealth Hospital
Damariscotta, Maine, 04543
Carle at The Riverfront
Danville, Illinois, 61832
Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis
Daphne, Alabama, 36526
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Decatur Memorial Hospital
Decatur, Illinois, 62526
Broward Health North
Deerfield Beach, Florida, 33064
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado, 80218
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
Bayhealth Hospital Kent Campus
Dover, Delaware, 19901
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201
Thomas Hospital
Fairhope, Alabama, 36532
MaineHealth Franklin Hospital
Farmington, Maine, 04938
Broward Health Medical Center
Fort Lauderdale, Florida, 33316
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, 60026
Lutheran Hospital - Cancer Centers of Colorado
Golden, Colorado, 80401
Nebraska Cancer Specialists/Oncology Hematology West PC
Grand Island, Nebraska, 68803
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, 81501
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
East Carolina University
Greenville, North Carolina, 27834
ECU Health Medical Center
Greenville, North Carolina, 27834
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651
Hartford Hospital
Hartford, Connecticut, 06102
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, 60035
Edwards Comprehensive Cancer Center
Huntington, West Virginia, 25701
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Dickinson County Healthcare System
Iron Mountain, Michigan, 49801
Freeman Health System
Joplin, Missouri, 64804
Mercy Hospital Joplin
Joplin, Missouri, 64804
Novant Health Cancer Institute - Kernersville
Kernersville, North Carolina, 27284
Kingman Regional Medical Center
Kingman, Arizona, 86401
ECU Health Oncology Kinston
Kinston, North Carolina, 28501
Good Samaritan Hospital - Cancer Centers of Colorado
Lafayette, Colorado, 80026
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102
Hope Cancer Care of Nevada
Las Vegas, Nevada, 89103
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada, 89144
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, 89169
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89183
Saint Mary's Regional Medical Center
Lewiston, Maine, 04240
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
Veterans Affairs Loma Linda Healthcare System
Loma Linda, California, 92357
Centra Alan B Pearson Regional Cancer Center
Lynchburg, Virginia, 24501
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Bayhealth Hospital Sussex Campus
Milford, Delaware, 19963
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548
Mobile Infirmary Medical Center
Mobile, Alabama, 36607
Monongalia Hospital
Morgantown, West Virginia, 26505
Morristown Medical Center
Morristown, New Jersey, 07960
Novant Health Cancer Institute - Mount Airy
Mount Airy, North Carolina, 27030
SSM Health Good Samaritan
Mount Vernon, Illinois, 62864
Saint Joseph Hospital
Nashua, New Hampshire, 03060
University Medical Center New Orleans
New Orleans, Louisiana, 70112
Children's Hospital New Orleans
New Orleans, Louisiana, 70118
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Newton Medical Center
Newton, New Jersey, 07860
MaineHealth Stephens Hospital
Norway, Maine, 04268
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, 28374
Chilton Medical Center
Pompton, New Jersey, 07444
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341
Maine Medical Partners Surgical Care
Portland, Maine, 04102
MaineHealth Maine Medical Center - Portland
Portland, Maine, 04102
MMP Surgical Care Casco Bay
Portland, Maine, 04102
Roger Williams Medical Center
Providence, Rhode Island, 02908
Valley Medical Center
Renton, Washington, 98055
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
Penobscot Bay Medical Center
Rockport, Maine, 04856
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401
Phelps Health Delbert Day Cancer Institute
Rolla, Missouri, 65401
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506
Salinas Valley Memorial
Salinas, California, 93901
Audie L Murphy VA Hospital
San Antonio, Texas, 78229
MaineHealth Cancer Care and IV Therapy - Sanford
Sanford, Maine, 04073
Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland
Saraland, Alabama, 36571
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405
Maine Children's Cancer Program
Scarborough, Maine, 04074
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine, 04074
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, 71103
MaineHealth Cancer Care and IV Therapy - South Portland
South Portland, Maine, 04106
MaineHealth Urology - South Portland
South Portland, Maine, 04106
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
Mercy Hospital Springfield
Springfield, Missouri, 65804
CoxHealth South Hospital
Springfield, Missouri, 65807
Mercy Infusion Center - Chippewa
St Louis, Missouri, 63109
Mercy Hospital South
St Louis, Missouri, 63128
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Mercy Hospital Saint Louis
St Louis, Missouri, 63141
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
Overlook Hospital
Summit, New Jersey, 07902
Tampa General Hospital
Tampa, Florida, 33606
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, 10461
Children's Hospital at Montefiore
The Bronx, New York, 10467
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467
Novant Health Cancer Institute - Thomasville
Thomasville, North Carolina, 27360
SMC Center for Hematology Oncology Union
Union, South Carolina, 29379
Carle Cancer Center
Urbana, Illinois, 61801
Illinois CancerCare - Washington
Washington, Illinois, 61571
Mercy Hospital Washington
Washington, Missouri, 63090
Marion L Shepard Cancer Center - ECU Health Beaufort Hospital
Washington, North Carolina, 27889
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, 54494
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, 98902
Puerto Rico3 sites
San Juan Community Oncology Group
San Juan, 00917
Centro Comprensivo de Cancer de UPR
San Juan, 00927
San Juan City Hospital
San Juan, 00936
About this study
Official title: Cancer Moonshot Biobank Research Protocol
This trial collects multiple tissue and blood samples, along with medical information, from cancer patients. The "Cancer Moonshot Biobank" is a longitudinal study. This means it collects and stores samples and information over time, throughout the course of a patient's cancer treatment. By looking at samples and information collected from the same people over time, researchers hope to better understand how cancer changes over time and over the course of medical treatments.
Read the detailed description
PRIMARY OBJECTIVE:
- To support current and future investigations into drug resistance and sensitivity and other National Cancer Institute (NCI)-sponsored cancer research initiatives through the procurement and distribution of multiple longitudinal biospecimens and associated data from a diverse group of cancer patients who are undergoing standard of care treatment at NCI Community Oncology Research Program (NCORP) sites and other National Clinical Trials Network (NCTN) sites.
SECONDARY OBJECTIVES:
- To provide a service of value to study participants and their medical providers through the performance of molecular profiling assays on tumor samples in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory and reporting of results to physicians and patients that they may opt to use in clinical management, including analysis of data for acquired resistance mechanisms.
II. To enable the development of patient-derived models such as cell lines and xenografts for cancer researchers through the provision of biospecimens from up to 20% of study participants to the NCI's Patient Derived Models Repository (PDMR), a national resource available to investigators.
III. To develop and implement robust approaches in patient and provider engagement to improve understanding of biobanking and its relationship to cancer research and increase representation of minority and underserved study participants in cancer research.
IV. To develop increased capabilities in United States (U.S.) community hospitals and clinics for contribution to cancer research through biobanking activities.
- To enable secondary research generated from the project through deposition of data in public repositories such as Cancer Research Data Commons (CRDC), The Cancer Imaging Archive (TCIA) and database of Genotypes and Phenotypes (dbGaP) and other potential NCI databases, including clinical, radiology and pathology data with an emphasis on treatment response and outcome data.
VI. To provide residual biospecimens and associated data from the project to the cancer research community.
OUTLINE:
Patients undergo collection of tissue samples during baseline and at time of disease progression and collection of blood samples throughout the study, including at time of disease progression. Patients with hematological malignancies also undergo collection of bone marrow and cerebral spinal fluid at the same time points. Archival blood and tissue, as well as bone marrow of patients with hematological malignancies, is also collected if available. Additionally, patients may undergo computed tomography (CT), positron emission tomography (PET)/CT and/or magnetic resonance imaging (MRI) throughout the study, and may undergo paracentesis on study. Patient medical records are reviewed, and data is collected for at least 5 years.
- Conditions
- Acute Myeloid Leukemia, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Clinical Stage IV Esophageal Adenocarcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
- Being tested
- Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Medical Chart Review, Paracentesis
- Medical subject headings
- Leukemia, Myeloid, Acute, Esophageal Neoplasms, Fallopian Tube Neoplasms, Stomach Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Melanoma, Prostatic 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, Sample Collection, Specimen Collection
Undergo collection of blood, tissue, bone marrow, and cerebral spinal fluid samples
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
Medical Chart ReviewOther
Also called Chart Review
Medical charts are reviewed and data is collected
ParacentesisProcedure or surgery
Undergo paracentesis
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Observational (biospecimen collection, chart review) | Patients undergo collection of tissue samples during baseline and at time of disease progression and collection of blood samples throughout the study, including at time of disease progression. Patients with hematological malignancies also undergo collection of bone marrow and cerebral spinal fluid at the same time points. Archival blood and tissue, as well as bone marrow of patients with hematological malignancies, is also collected if available. Additionally, patients may undergo CT, PET/CT and/or MRI throughout the study, and may undergo paracentesis on study. Patient medical records are reviewed, and data is collected for at least 5 years. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Other: Medical Chart Review; Procedure: Paracentesis; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procure, store and distribute longitudinal biospecimens and associated clinical data
Will procure, store and distribute longitudinal biospecimens and associated clinical data for current and future cancer research in order to elucidate molecular mechanisms of sensitivity and intrinsic or acquired resistance to standard of care systemic therapies, including immunotherapy. Cases will be grouped according to patient demographics, cancer type and treatment regimen. Statistical analysis will be descriptive and will be analyzed for each Biospecimen Source Site (BSS) as well as study aggregate.
Measured: Up to 10 years
Percentage of enrolled patients by cancer type and treatment regimen overall
Will assess the percentage of enrolled patients by cancer type and treatment regimen overall and those who contribute samples to the Drug Resistance and Sensitivity Network and other approved investigators. Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate.
Measured: Until completion of biospecimen collection, up to 3 years
Percentage of minority and underserved study participants accrued
Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate.
Measured: Until completion of biospecimen collection, up to 3 years
Secondary outcomes (7)
Pan-cancer gene panel tumor next generation sequencing test
Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate.
Measured: Until completion of biospecimen collection, up to 3 years
Cancer Research Data Commons, The Cancer Imaging Archive and database of Genotypes and Phenotypes data contribution
Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate.
Measured: Until completion of biospecimen collection, up to 3 years
Percentage of minority and underserved study participants accrued
Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate.
Measured: Until completion of biospecimen collection, up to 3 years
Percentage of enrolled patients for whom molecular profiling is attempted
Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate. Will also be assessed by patient demographics, cancer type and treatment regimen.
Measured: Until completion of biospecimen collection, up to 3 years
Percentage of enrolled patients for whom molecular profiling results are generated
Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate. Will also be assessed by patient demographics, cancer type and treatment regimen.
Measured: Until completion of biospecimen collection, up to 3 years
Percentage of enrolled patients for whom samples are obtained at each longitudinal timepoint
Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate. Will also be assessed by patient demographics, cancer type and treatment regimen.
Measured: Until completion of biospecimen collection, up to 3 years
Percentage of collected biospecimens that are delivered to the Patient Derived Models Repository
Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate. Will also be assessed by patient demographics, cancer type and treatment regimen.
Measured: Until completion of biospecimen collection, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start11 Nov 2020
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (estimated)
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
- NCT04314401
- Sponsor's protocol ID
- NCI-2020-00750
- Other IDs
- NCI-2020-00750, 10323, 10323
- Status last verified
- Oct 2026
- First submitted
- 18 Mar 2020
- Last updated
- 5 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