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Collection of cancer samples and data for research

Cancer Moonshot Biobank Research Protocol

Observational National Cancer Institute (NCI) · NCT04314401

This study collects blood and tissue samples from cancer patients to help researchers learn more about how cancer changes over time and how different treatments work, especially for underrepresented groups.

Quick facts

Study typeObservational
Enrollment1000 (estimated)
Ages13 Years and up
SexAll
SponsorNational Cancer Institute (NCI) NIH
Drugs / interventionschemotherapy, radiation
Locations150 sites (Daphne, Alabama and 149 other locations)
Trial IDNCT04314401 on ClinicalTrials.gov

What this trial studies

This observational study collects tissue and blood samples, along with medical information, from cancer patients undergoing standard treatment. The Cancer Moonshot Biobank aims to gather longitudinal data to understand how cancer evolves over time and in response to treatments. It supports research into drug resistance and sensitivity while providing molecular profiling to assist in clinical management. The study also focuses on increasing representation of minority and underserved populations in cancer research.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with specific advanced cancers such as acute myeloid leukemia, stage III/IV breast cancer, and stage IV gastric or esophageal cancers.

Not a fit: Patients with early-stage cancers or those not undergoing standard treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of cancer progression and treatment responses, leading to improved patient outcomes.

How similar studies have performed: Other studies utilizing biobanking and longitudinal data collection have shown promise in advancing cancer research, making this approach both relevant and potentially impactful.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Daphne, Alabama and 149 other locations

+100 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Myeloid LeukemiaAnatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Clinical Stage IV Esophageal Adenocarcinoma AJCC v8Clinical Stage IV Gastric Cancer AJCC v8Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8Esophageal CarcinomaFallopian Tube Carcinoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.