National Cancer Institute "Cancer Moonshot Biobank"

May 12, 2026 updated by: National Cancer Institute (NCI)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. 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:

I. 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.

V. 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.

Study Type

Observational

Enrollment (Estimated)

1600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00917
        • San Juan Community Oncology Group
      • San Juan, Puerto Rico, 00927
        • Centro Comprensivo de Cancer de UPR
      • San Juan, Puerto Rico, 00936
        • San Juan City Hospital
  • United States
    • Alabama
      • Daphne, Alabama, United States, 36526
        • Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis
      • Fairhope, Alabama, United States, 36532
        • Thomas Hospital
      • Mobile, Alabama, United States, 36607
        • Mobile Infirmary Medical Center
      • Saraland, Alabama, United States, 36571
        • Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland
    • Arizona
      • Kingman, Arizona, United States, 86401
        • Kingman Regional Medical Center
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Mercy Hospital Fort Smith
    • California
      • Arroyo Grande, California, United States, 93420
        • PCR Oncology
      • Bakersfield, California, United States, 93301
        • AIS Cancer Center at San Joaquin Community Hospital
      • Loma Linda, California, United States, 92357
        • Veterans Affairs Loma Linda Healthcare System
      • Salinas, California, United States, 93901
        • Salinas Valley Memorial
    • Colorado
      • Brighton, Colorado, United States, 80601
        • Intermountain Health Platte Valley Hospital
      • Denver, Colorado, United States, 80218
        • Saint Joseph Hospital - Cancer Centers of Colorado
      • Golden, Colorado, United States, 80401
        • Lutheran Hospital - Cancer Centers of Colorado
      • Grand Junction, Colorado, United States, 81501
        • Saint Mary's Hospital and Regional Medical Center
      • Lafayette, Colorado, United States, 80026
        • Good Samaritan Hospital - Cancer Centers of Colorado
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
    • Delaware
      • Dover, Delaware, United States, 19901
        • Bayhealth Hospital Kent Campus
      • Milford, Delaware, United States, 19963
        • Bayhealth Hospital Sussex Campus
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Boca Raton Regional Hospital
      • Deerfield Beach, Florida, United States, 33064
        • Broward Health North
      • Fort Lauderdale, Florida, United States, 33316
        • Broward Health Medical Center
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital
      • Savannah, Georgia, United States, 31405
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
    • Illinois
      • Bloomington, Illinois, United States, 61704
        • Illinois CancerCare-Bloomington
      • Chicago, Illinois, United States, 60612
        • John H Stroger Jr Hospital of Cook County
      • Chicago, Illinois, United States, 60625
        • Swedish Covenant Hospital
      • Danville, Illinois, United States, 61832
        • Carle at The Riverfront
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, United States, 62526
        • Cancer Care Specialists of Illinois - Decatur
      • Evanston, Illinois, United States, 60201
        • NorthShore University HealthSystem-Evanston Hospital
      • Galesburg, Illinois, United States, 61401
        • Illinois CancerCare-Galesburg
      • Glenview, Illinois, United States, 60026
        • NorthShore University HealthSystem-Glenbrook Hospital
      • Highland Park, Illinois, United States, 60035
        • NorthShore University HealthSystem-Highland Park Hospital
      • Mattoon, Illinois, United States, 61938
        • Carle Physician Group-Mattoon/Charleston
      • Mount Vernon, Illinois, United States, 62864
        • SSM Health Good Samaritan
      • Pekin, Illinois, United States, 61554
        • Illinois CancerCare-Pekin
      • Peoria, Illinois, United States, 61615
        • Illinois CancerCare-Peoria
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
      • Washington, Illinois, United States, 61571
        • Illinois CancerCare - Washington
    • Iowa
      • Ames, Iowa, United States, 50010
        • McFarland Clinic - Ames
      • Bettendorf, Iowa, United States, 52722
        • University of Iowa Healthcare Cancer Services Quad Cities
      • Cedar Rapids, Iowa, United States, 52403
        • Oncology Associates at Mercy Medical Center
      • Cedar Rapids, Iowa, United States, 52402
        • Physicians' Clinic of Iowa PC
      • Des Moines, Iowa, United States, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, United States, 50309
        • Blank Children's Hospital
      • Des Moines, Iowa, United States, 50309
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
      • Iowa City, Iowa, United States, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Our Lady of the Lake Physician Group
      • New Orleans, Louisiana, United States, 70118
        • Children's Hospital New Orleans
      • New Orleans, Louisiana, United States, 70112
        • University Medical Center New Orleans
      • Shreveport, Louisiana, United States, 71103
        • LSU Health Sciences Center at Shreveport
    • Maine
      • Augusta, Maine, United States, 04330
        • Harold Alfond Center for Cancer Care
      • Belfast, Maine, United States, 04915
        • MaineHealth Waldo Hospital
      • Biddeford, Maine, United States, 04005
        • MaineHealth Maine Medical Center - Biddeford
      • Brunswick, Maine, United States, 04011
        • MaineHealth Cancer Care and IV Therapy - Brunswick
      • Brunswick, Maine, United States, 04011
        • Mid Coast Hospital
      • Damariscotta, Maine, United States, 04543
        • MaineHealth LincolnHealth Hospital
      • Farmington, Maine, United States, 04938
        • MaineHealth Franklin Hospital
      • Lewiston, Maine, United States, 04240
        • Saint Mary's Regional Medical Center
      • Norway, Maine, United States, 04268
        • MaineHealth Stephens Hospital
      • Portland, Maine, United States, 04102
        • Maine Medical Partners Surgical Care
      • Portland, Maine, United States, 04102
        • MMP Surgical Care Casco Bay
      • Portland, Maine, United States, 04102
        • MaineHealth Maine Medical Center - Portland
      • Rockport, Maine, United States, 04856
        • Penobscot Bay Medical Center
      • Sanford, Maine, United States, 04073
        • MaineHealth Cancer Care and IV Therapy - Sanford
      • Scarborough, Maine, United States, 04074
        • Maine Children's Cancer Program
      • Scarborough, Maine, United States, 04074
        • MaineHealth Maine Medical Center- Scarborough
      • South Portland, Maine, United States, 04106
        • MaineHealth Cancer Care and IV Therapy - South Portland
      • South Portland, Maine, United States, 04106
        • MaineHealth Urology - South Portland
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
      • Brighton, Michigan, United States, 48114
        • Trinity Health Medical Center - Brighton
      • Canton, Michigan, United States, 48188
        • Trinity Health Medical Center - Canton
      • Chelsea, Michigan, United States, 48118
        • Chelsea Hospital
      • Grand Rapids, Michigan, United States, 49503
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
      • Iron Mountain, Michigan, United States, 49801
        • Dickinson County Healthcare System
      • Livonia, Michigan, United States, 48154
        • Trinity Health Saint Mary Mercy Livonia Hospital
      • Pontiac, Michigan, United States, 48341
        • Trinity Health Saint Joseph Mercy Oakland Hospital
    • Missouri
      • Ballwin, Missouri, United States, 63011
        • Mercy Oncology and Hematology - Clayton-Clarkson
      • Joplin, Missouri, United States, 64804
        • Freeman Health System
      • Joplin, Missouri, United States, 64804
        • Mercy Hospital Joplin
      • Rolla, Missouri, United States, 65401
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Rolla, Missouri, United States, 65401
        • Phelps Health Delbert Day Cancer Institute
      • Saint Joseph, Missouri, United States, 64506
        • Heartland Regional Medical Center
      • Springfield, Missouri, United States, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, United States, 65804
        • Mercy Hospital Springfield
      • St Louis, Missouri, United States, 63131
        • Missouri Baptist Medical Center
      • St Louis, Missouri, United States, 63109
        • Mercy Infusion Center - Chippewa
      • St Louis, Missouri, United States, 63141
        • Mercy Hospital Saint Louis
      • St Louis, Missouri, United States, 63128
        • Mercy Hospital South
      • Washington, Missouri, United States, 63090
        • Mercy Hospital Washington
    • Montana
      • Billings, Montana, United States, 59102
        • Saint Vincent Frontier Cancer Center
      • Butte, Montana, United States, 59701
        • Saint James Community Hospital and Cancer Treatment Center
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Nebraska Cancer Specialists/Oncology Hematology West PC
    • Nevada
      • Carson City, Nevada, United States, 89703
        • Carson Tahoe Regional Medical Center
      • Las Vegas, Nevada, United States, 89102
        • OptumCare Cancer Care at Charleston
      • Las Vegas, Nevada, United States, 89135
        • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
      • Las Vegas, Nevada, United States, 89144
        • Comprehensive Cancer Centers of Nevada - Town Center
      • Las Vegas, Nevada, United States, 89148
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada - Central Valley
      • Las Vegas, Nevada, United States, 89103
        • Hope Cancer Care of Nevada
      • Las Vegas, Nevada, United States, 89183
        • OptumCare Cancer Care at Fort Apache
    • New Hampshire
      • Nashua, New Hampshire, United States, 03060
        • Saint Joseph Hospital
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Morristown Medical Center
      • Newton, New Jersey, United States, 07860
        • Newton Medical Center
      • Pompton, New Jersey, United States, 07444
        • Chilton Medical Center
      • Summit, New Jersey, United States, 07902
        • Overlook Hospital
    • New York
      • New York, New York, United States, 10032
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
      • The Bronx, New York, United States, 10461
        • Montefiore Medical Center-Einstein Campus
      • The Bronx, New York, United States, 10467
        • Children's Hospital at Montefiore
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center - Moses Campus
      • The Bronx, New York, United States, 10461
        • Montefiore Medical Center-Weiler Hospital
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Novant Health Presbyterian Medical Center
      • Greenville, North Carolina, United States, 27834
        • East Carolina University
      • Greenville, North Carolina, United States, 27834
        • ECU Health Medical Center
      • Kernersville, North Carolina, United States, 27284
        • Novant Health Cancer Institute - Kernersville
      • Kinston, North Carolina, United States, 28501
        • ECU Health Oncology Kinston
      • Mount Airy, North Carolina, United States, 27030
        • Novant Health Cancer Institute - Mount Airy
      • Pinehurst, North Carolina, United States, 28374
        • FirstHealth of the Carolinas-Moore Regional Hospital
      • Thomasville, North Carolina, United States, 27360
        • Novant Health Cancer Institute - Thomasville
      • Washington, North Carolina, United States, 27889
        • Marion L Shepard Cancer Center - ECU Health Beaufort Hospital
      • Winston-Salem, North Carolina, United States, 27103
        • Novant Health Forsyth Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Mercy Hospital Oklahoma City
    • Rhode Island
      • Providence, Rhode Island, United States, 02908
        • Roger Williams Medical Center
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Prisma Health Richland Hospital
      • Columbia, South Carolina, United States, 29220
        • Prisma Health Baptist Hospital
      • Gaffney, South Carolina, United States, 29341
        • Gibbs Cancer Center-Gaffney
      • Greenville, South Carolina, United States, 29605
        • Prisma Health Greenville Memorial Hospital
      • Greer, South Carolina, United States, 29651
        • Gibbs Cancer Center-Pelham
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Medical Center
      • Union, South Carolina, United States, 29379
        • SMC Center for Hematology Oncology Union
    • Texas
      • San Antonio, Texas, United States, 78229
        • Audie L Murphy VA Hospital
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • Centra Alan B Pearson Regional Cancer Center
      • Richmond, Virginia, United States, 23235
        • VCU Massey Cancer Center at Stony Point
      • Richmond, Virginia, United States, 23298
        • VCU Massey Comprehensive Cancer Center
    • Washington
      • Renton, Washington, United States, 98055
        • Valley Medical Center
      • Yakima, Washington, United States, 98902
        • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • Edwards Comprehensive Cancer Center
      • Morgantown, West Virginia, United States, 26505
        • Monongalia Hospital
    • Wisconsin
      • Eau Claire, Wisconsin, United States, 54701
        • Marshfield Medical Center-EC Cancer Center
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Medical Center-Marshfield
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora Saint Luke's Medical Center
      • Minocqua, Wisconsin, United States, 54548
        • Marshfield Medical Center - Minocqua
      • Rice Lake, Wisconsin, United States, 54868
        • Marshfield Medical Center-Rice Lake
      • Stevens Point, Wisconsin, United States, 54482
        • Marshfield Medical Center-River Region at Stevens Point
      • Weston, Wisconsin, United States, 54476
        • Marshfield Medical Center - Weston
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Marshfield Clinic - Wisconsin Rapids Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing treatment for cancer types with commercially available therapies.

Description

Inclusion Criteria:

  • 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
    • 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)

Exclusion Criteria:

  • 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

    • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Procedure: Computed Tomography
Undergo CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
  • Diagnostic CAT Scan
  • Diagnostic CAT Scan Service Type
Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • PT
  • Positron emission tomography (procedure)
Procedure: Biospecimen Collection
Undergo collection of blood, tissue, bone marrow, and cerebral spinal fluid samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Sample Collection
Other: Medical Chart Review
Medical charts are reviewed and data is collected
Other Names:
  • Chart Review
Procedure: Paracentesis
Undergo paracentesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procure, store and distribute longitudinal biospecimens and associated clinical data
Time Frame: Up to 10 years
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.
Up to 10 years
Percentage of enrolled patients by cancer type and treatment regimen overall
Time Frame: Until completion of biospecimen collection, up to 3 years
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.
Until completion of biospecimen collection, up to 3 years
Percentage of minority and underserved study participants accrued
Time Frame: Until completion of biospecimen collection, up to 3 years
Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate.
Until completion of biospecimen collection, up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of minority and underserved study participants accrued
Time Frame: Until completion of biospecimen collection, up to 3 years
Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate.
Until completion of biospecimen collection, up to 3 years
Pan-cancer gene panel tumor next generation sequencing test
Time Frame: Until completion of biospecimen collection, up to 3 years
Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate.
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
Time Frame: Until completion of biospecimen collection, up to 3 years
Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate.
Until completion of biospecimen collection, up to 3 years
Percentage of enrolled patients for whom molecular profiling is attempted
Time Frame: Until completion of biospecimen collection, up to 3 years
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.
Until completion of biospecimen collection, up to 3 years
Percentage of enrolled patients for whom molecular profiling results are generated
Time Frame: Until completion of biospecimen collection, up to 3 years
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.
Until completion of biospecimen collection, up to 3 years
Percentage of enrolled patients for whom samples are obtained at each longitudinal timepoint
Time Frame: Until completion of biospecimen collection, up to 3 years
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.
Until completion of biospecimen collection, up to 3 years
Percentage of collected biospecimens that are delivered to the Patient Derived Models Repository
Time Frame: Until completion of biospecimen collection, up to 3 years
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.
Until completion of biospecimen collection, up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Lyndsay N Harris, National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2020

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

March 18, 2020

First Submitted That Met QC Criteria

March 18, 2020

First Posted (Actual)

March 19, 2020

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2020-00750 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • 10323 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Malignant Solid Neoplasm

Clinical Trials on Magnetic Resonance Imaging

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe