Cancer Moonshot Biobank Research Protocol

Cancer Moonshot Biobank: A Long-Term Study of Cancer Evolution

NCT: NCT04314401 · Status: ACTIVE NOT RECRUITING · Phase: N/A · Sponsor: National Cancer Institute (NCI) · Started: 2020-11-11 · Est. Completion: 2027-04-30

Plain English Summary

National Cancer Institute "Cancer Moonshot Biobank" is a Not Applicable clinical trial sponsored by National Cancer Institute (NCI) studying 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. This study collects biological samples (like blood and tissue) and medical information from cancer patients over time. It is for patients diagnosed with specific types of cancer, including leukemia, breast, lung, prostate, and others. Participation involves providing samples and allowing researchers to access your medical records. There are no alternative treatments offered within this study; it is purely for research purposes. The trial aims to enroll 1600 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients aged 13 and older with specific types and stages of cancer are eligible. Patients must be undergoing diagnostic workup, starting new treatment, progressing on treatment, or currently on treatment without progression. Specific requirements for providing fresh or archival tissue and blood samples apply. Patients receiving non-standard investigational treatments may not be eligible. This trial is studying 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, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures focus on collecting and storing samples and data over time to help researchers learn more about cancer's progression. The specific primary outcome measures are: Procure, store and distribute longitudinal biospecimens and associated clinical data (Up to 10 years); Percentage of enrolled patients by cancer type and treatment regimen overall (Until completion of biospecimen collection, up to 3 years); Percentage of minority and underserved study participants accrued (Until completion of biospecimen collection, up to 3 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it aims to understand how cancer changes over time and during treatment, which could lead to better future therapies. This research targets 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, where improved treatment options are needed.

Investor Insight

This is a large-scale observational study sponsored by the National Cancer Institute, indicating a significant commitment to cancer research and data collection for future therapeutic development. The large enrollment target of 1600 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if your specific cancer type and stage are eligible for this study. Understand that participation involves providing biological samples and allowing access to your medical history. Be prepared for potential procedures like blood draws, tissue biopsies, or fluid collection. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility 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-

Trial Locations

Frequently Asked Questions

What is clinical trial NCT04314401?

NCT04314401 is a Not Applicable OBSERVATIONAL study titled "National Cancer Institute "Cancer Moonshot Biobank"." It is currently active, not recruiting and is sponsored by National Cancer Institute (NCI). The trial targets enrollment of 1600 participants.

What conditions does NCT04314401 study?

This trial investigates treatments for 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. The primary condition under study is Acute Myeloid Leukemia.

What treatments are being tested in NCT04314401?

The interventions being studied include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Medical Chart Review (OTHER), Paracentesis (PROCEDURE). Undergo collection of blood, tissue, bone marrow, and cerebral spinal fluid samples

What does Not Applicable mean for NCT04314401?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT04314401?

This trial is currently "Active, Not Recruiting." It started on 2020-11-11. The estimated completion date is 2027-04-30.

Who is sponsoring NCT04314401?

NCT04314401 is sponsored by National Cancer Institute (NCI). The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT04314401?

The trial aims to enroll 1600 participants. The trial status is active, not recruiting.

How is NCT04314401 designed?

This is a observational study.

What are the primary outcomes being measured in NCT04314401?

The primary outcome measures are: Procure, store and distribute longitudinal biospecimens and associated clinical data (Up to 10 years); Percentage of enrolled patients by cancer type and treatment regimen overall (Until completion of biospecimen collection, up to 3 years); Percentage of minority and underserved study participants accrued (Until completion of biospecimen collection, up to 3 years). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT04314401 being conducted?

This trial is being conducted at 20 sites, including Daphne, Alabama; Fairhope, Alabama; Mobile, Alabama; Saraland, Alabama and 16 more sites (United States).

Where can I find official information about NCT04314401?

The official record for NCT04314401 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04314401. This government database provides the most up-to-date and detailed information about the trial.

What is NCT04314401 testing in simple terms?

This study collects biological samples (like blood and tissue) and medical information from cancer patients over time. It is for patients diagnosed with specific types of cancer, including leukemia, breast, lung, prostate, and others.

Why is this trial significant?

This trial matters because it aims to understand how cancer changes over time and during treatment, which could lead to better future therapies.

What are the potential risks of participating in NCT04314401?

Risks are primarily associated with the procedures for sample collection, such as bleeding, infection, or discomfort at the biopsy site. There are no direct treatment risks as this is an observational study. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT04314401?

Ask your doctor if your specific cancer type and stage are eligible for this study. Understand that participation involves providing biological samples and allowing access to your medical history. Be prepared for potential procedures like blood draws, tissue biopsies, or fluid collection. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT04314401 signal from an investment perspective?

This is a large-scale observational study sponsored by the National Cancer Institute, indicating a significant commitment to cancer research and data collection for future therapeutic development. This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participation involves providing samples and allowing researchers to access your medical records. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.