National Cancer Institute "Cancer Moonshot Biobank"

Description

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.

Conditions

Acute Myeloid Leukemia, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Clinical Stage IV Esophageal Adenocarcinoma AJCC v8, Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Lung Non-Small Cell Carcinoma, Lung Small Cell Carcinoma, Malignant Solid Neoplasm, Metastatic Prostate Carcinoma, Multiple Myeloma, Stage III Lung Cancer AJCC v8, Stage III Ovarian Cancer AJCC v8, Stage IV Colorectal Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IV Ovarian Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8

Study Overview

Study Details

Study overview

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.

Cancer Moonshot Biobank Research Protocol

National Cancer Institute "Cancer Moonshot Biobank"

Condition
Acute Myeloid Leukemia
Intervention / Treatment

-

Contacts and Locations

Fairhope

Thomas Hospital, Fairhope, Alabama, United States, 36532

Mobile

Mobile Infirmary Medical Center, Mobile, Alabama, United States, 36607

Kingman

Kingman Regional Medical Center, Kingman, Arizona, United States, 86401

Fort Smith

Mercy Hospital Fort Smith, Fort Smith, Arkansas, United States, 72903

Arroyo Grande

PCR Oncology, Arroyo Grande, California, United States, 93420

Bakersfield

AIS Cancer Center at San Joaquin Community Hospital, Bakersfield, California, United States, 93301

Golden

Lutheran Hospital - Cancer Centers of Colorado, Golden, Colorado, United States, 80401

Hartford

Hartford Hospital, Hartford, Connecticut, United States, 06102

Dover

Bayhealth Hospital Kent Campus, Dover, Delaware, United States, 19901

Milford

Bayhealth Hospital Sussex Campus, Milford, Delaware, United States, 19963

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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 optimum surface area of 25 mm\^2 or 3-5 mL cryopreserved bone marrow aspirate to yield 200 million bone marrow mononuclear cells, 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
  • * Age 13 or older
  • * Any sex and any gender
  • * 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)
  • * Treated with or has already begun treatment with a non-standard of care therapeutic agent (investigational) in an interventional clinical trial
  • * 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

Ages Eligible for Study

13 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

National Cancer Institute (NCI),

Helen M Moore, PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)

Study Record Dates

2025-09-16