National Cancer Institute "Cancer Moonshot Biobank"

Running, not enrolling

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT04314401

Run by

National Cancer Institute (NCI)

People needed

1600

Starts

2020-11-11

Expected to finish

2027-04-30

Last updated by the study team

2026-05-13

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis — Daphne, Alabama, United States

Full record on ClinicalTrials.gov

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