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ACTIVE NOT RECRUITING

NCT04314401

National Cancer Institute "Cancer Moonshot Biobank"

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

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. 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.

Official title: Cancer Moonshot Biobank Research Protocol

Key Details

Gender

All

Age Range

13 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1600

Start Date

2020-11-11

Completion Date

2027-04-30

Last Updated

2026-04-09

Healthy Volunteers

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 Esophageal Carcinoma Fallopian Tube Carcinoma Gastric Carcinoma Hormone Receptor-Positive Breast Carcinoma Invasive Breast Carcinoma Lung Non-Small Cell Carcinoma Lung Small Cell Carcinoma Malignant Solid Neoplasm Melanoma Metastatic Prostate Carcinoma Multiple Myeloma Ovarian Carcinoma Ovarian High Grade Serous Adenocarcinoma Primary Peritoneal Carcinoma Stage III Fallopian Tube Cancer AJCC v8 Stage III Lung Cancer AJCC v8 Stage III Ovarian Cancer AJCC v8 Stage IV Colorectal Cancer AJCC v8 Stage IV Fallopian Tube Cancer AJCC v8 Stage IV Lung Cancer AJCC v8 Stage IV Ovarian Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8 Triple-Negative Breast Carcinoma

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood, tissue, bone marrow, and cerebral spinal fluid samples

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

OTHER

Medical Chart Review

Medical charts are reviewed and data is collected

PROCEDURE

Paracentesis

Undergo paracentesis

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

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

Locations (151)

Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis

Daphne, Alabama, United States

Thomas Hospital

Fairhope, Alabama, United States

Mobile Infirmary Medical Center

Mobile, Alabama, United States

Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland

Saraland, Alabama, United States

Kingman Regional Medical Center

Kingman, Arizona, United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

PCR Oncology

Arroyo Grande, California, United States

AIS Cancer Center at San Joaquin Community Hospital

Bakersfield, California, United States

Veterans Affairs Loma Linda Healthcare System

Loma Linda, California, United States

Salinas Valley Memorial

Salinas, California, United States

Intermountain Health Platte Valley Hospital

Brighton, Colorado, United States

Saint Joseph Hospital - Cancer Centers of Colorado

Denver, Colorado, United States

Lutheran Hospital - Cancer Centers of Colorado

Golden, Colorado, United States

Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, United States

Good Samaritan Hospital - Cancer Centers of Colorado

Lafayette, Colorado, United States

Hartford Hospital

Hartford, Connecticut, United States

Bayhealth Hospital Kent Campus

Dover, Delaware, United States

Bayhealth Hospital Sussex Campus

Milford, Delaware, United States

Boca Raton Regional Hospital

Boca Raton, Florida, United States

Broward Health North

Deerfield Beach, Florida, United States

Broward Health Medical Center

Fort Lauderdale, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

Northside Hospital

Atlanta, Georgia, United States

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, United States

Swedish Covenant Hospital

Chicago, Illinois, United States

Carle at The Riverfront

Danville, Illinois, United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois, United States

NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois, United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

SSM Health Good Samaritan

Mount Vernon, Illinois, United States

Illinois CancerCare-Pekin

Pekin, Illinois, United States

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Illinois CancerCare - Washington

Washington, Illinois, United States

McFarland Clinic - Ames

Ames, Iowa, United States

University of Iowa Healthcare Cancer Services Quad Cities

Bettendorf, Iowa, United States

Physicians' Clinic of Iowa PC

Cedar Rapids, Iowa, United States

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, United States

Blank Children's Hospital

Des Moines, Iowa, United States

Iowa Methodist Medical Center

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, United States

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

Our Lady of the Lake Physician Group

Baton Rouge, Louisiana, United States

University Medical Center New Orleans

New Orleans, Louisiana, United States

Children's Hospital New Orleans

New Orleans, Louisiana, United States

LSU Health Sciences Center at Shreveport

Shreveport, Louisiana, United States

Harold Alfond Center for Cancer Care

Augusta, Maine, United States

MaineHealth Waldo Hospital

Belfast, Maine, United States

MaineHealth Maine Medical Center - Biddeford

Biddeford, Maine, United States

MaineHealth Cancer Care and IV Therapy - Brunswick

Brunswick, Maine, United States

Mid Coast Hospital

Brunswick, Maine, United States

MaineHealth LincolnHealth Hospital

Damariscotta, Maine, United States

MaineHealth Franklin Hospital

Farmington, Maine, United States

Saint Mary's Regional Medical Center

Lewiston, Maine, United States

MaineHealth Stephens Hospital

Norway, Maine, United States

Maine Medical Partners Surgical Care

Portland, Maine, United States

MaineHealth Maine Medical Center - Portland

Portland, Maine, United States

MMP Surgical Care Casco Bay

Portland, Maine, United States

Penobscot Bay Medical Center

Rockport, Maine, United States

MaineHealth Cancer Care and IV Therapy - Sanford

Sanford, Maine, United States

Maine Children's Cancer Program

Scarborough, Maine, United States

MaineHealth Maine Medical Center- Scarborough

Scarborough, Maine, United States

MaineHealth Cancer Care and IV Therapy - South Portland

South Portland, Maine, United States

MaineHealth Urology - South Portland

South Portland, Maine, United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, United States

Trinity Health Medical Center - Brighton

Brighton, Michigan, United States

Trinity Health Medical Center - Canton

Canton, Michigan, United States

Chelsea Hospital

Chelsea, Michigan, United States

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, United States

Dickinson County Healthcare System

Iron Mountain, Michigan, United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, United States

Mercy Oncology and Hematology - Clayton-Clarkson

Ballwin, Missouri, United States

Freeman Health System

Joplin, Missouri, United States

Mercy Hospital Joplin

Joplin, Missouri, United States

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, United States

Phelps Health Delbert Day Cancer Institute

Rolla, Missouri, United States

Heartland Regional Medical Center

Saint Joseph, Missouri, United States

Mercy Hospital Springfield

Springfield, Missouri, United States

CoxHealth South Hospital

Springfield, Missouri, United States

Mercy Infusion Center - Chippewa

St Louis, Missouri, United States

Mercy Hospital South

St Louis, Missouri, United States

Missouri Baptist Medical Center

St Louis, Missouri, United States

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Mercy Hospital Washington

Washington, Missouri, United States

Saint Vincent Frontier Cancer Center

Billings, Montana, United States

Saint James Community Hospital and Cancer Treatment Center

Butte, Montana, United States

Nebraska Cancer Specialists/Oncology Hematology West PC

Grand Island, Nebraska, United States

Carson Tahoe Regional Medical Center

Carson City, Nevada, United States

OptumCare Cancer Care at Seven Hills

Henderson, Nevada, United States

OptumCare Cancer Care at Charleston