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National Cancer Institute "Cancer Moonshot Biobank"

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04314401
Recruitment Status : Recruiting
First Posted : March 19, 2020
Last Update Posted : April 20, 2022
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief 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.

Condition or disease Intervention/treatment
Acute Myeloid Leukemia Castration-Resistant Prostate Carcinoma Clinical Stage III Cutaneous Melanoma AJCC v8 Clinical Stage IV Cutaneous Melanoma AJCC v8 Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8 Lung Non-Small Cell Carcinoma Lung Small Cell Carcinoma Malignant Solid Neoplasm Pathologic Stage III Cutaneous Melanoma AJCC v8 Pathologic Stage IIIA Cutaneous Melanoma AJCC v8 Pathologic Stage IIIB Cutaneous Melanoma AJCC v8 Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 Pathologic Stage IIID Cutaneous Melanoma AJCC v8 Pathologic Stage IV Cutaneous Melanoma AJCC v8 Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8 Plasma Cell Myeloma Stage III Lung Cancer AJCC v8 Stage IIIA Lung Cancer AJCC v8 Stage IIIB Lung Cancer AJCC v8 Stage IIIC Lung Cancer AJCC v8 Stage IV Colorectal Cancer AJCC v8 Stage IV Lung Cancer AJCC v8 Stage IV Prostate Cancer AJCC v8 Stage IVA Colorectal Cancer AJCC v8 Stage IVA Lung Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8 Stage IVB Colorectal Cancer AJCC v8 Stage IVB Lung Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8 Stage IVC Colorectal Cancer AJCC v8 Procedure: Biospecimen Collection Other: Medical Chart Review

Detailed Description:

PRIMARY OBJECTIVE:

I. To support current and future investigations into drug resistance and sensitivity and other National Cancer Institute (NCI)-sponsored cancer research initiatives through the procurement and distribution of multiple longitudinal biospecimens and associated data from a diverse group of cancer patients who are undergoing standard of care treatment at NCI Community Oncology Research Program (NCORP) sites.

SECONDARY OBJECTIVES:

I. To provide a service of value to study participants and their medical providers through the performance of molecular profiling assays on tumor samples in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory and reporting of results to physicians and patients that they may opt to use in clinical management, including analysis of data for acquired resistance mechanisms.

II. To enable the development of patient-derived models such as cell lines and xenografts for cancer researchers through the provision of biospecimens from 20% of study participants to the NCI's Patient Derived Models Repository (PDMR), a national resource available to investigators.

III. To develop and implement robust approaches in patient and provider engagement to improve understanding of biobanking and its relationship to cancer research and increase representation of minority and underserved study participants in cancer research.

IV. To develop increased capabilities in United States (U.S.) community hospitals and clinics for contribution to cancer research through biobanking activities.

V. To enable secondary research generated from the project through deposition of data in public repositories such as Cancer Research Data Commons (CRDC), The Cancer Imaging Archive (TCIA) and database of Genotypes and Phenotypes (dbGAP), including clinical, radiology and pathology data with an emphasis on treatment response and outcome data.

VI. To provide residual biospecimens and associated data from the project to the cancer research community.

OUTLINE:

Patients undergo collection of tissue and blood samples prior to initiation of treatment, during treatment, and at disease progression. Patients with hematological malignancies also undergo collection of bone marrow and cerebral spinal fluid at the same time points. Archival blood and tissue, as well as bone marrow of patients with hematological malignancies, is also collected, if available. Patient medical records are reviewed, and data is collected for at least 10 years.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cancer Moonshot Biobank Research Protocol
Actual Study Start Date : September 17, 2020
Estimated Primary Completion Date : September 16, 2025
Estimated Study Completion Date : September 16, 2025


Group/Cohort Intervention/treatment
Ancillary-correlative (biospecimen collection, chart review)
Patients undergo collection of tissue and blood samples prior to initiation of treatment, during treatment, and at disease progression. Patients with hematological malignancies also undergo collection of bone marrow and cerebral spinal fluid at the same time points. Archival blood and tissue, as well as bone marrow of patients with hematological malignancies, is also collected, if available. Patient medical records are reviewed, and data is collected for at least 10 years.
Procedure: Biospecimen Collection
Undergo collection of blood, tissue, bone marrow, and cerebral spinal fluid samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected

Other: Medical Chart Review
Medical charts are reviewed and data is collected
Other Name: Chart Review




Primary Outcome Measures :
  1. Procure, store and distribute longitudinal biospecimens and associated clinical data [ Time Frame: Up to 10 years ]
    Will procure, store and distribute longitudinal biospecimens and associated clinical data for current and future cancer research in order to elucidate molecular mechanisms of sensitivity and intrinsic or acquired resistance to standard of care systemic therapies, including immunotherapy. Cases will be grouped according to patient demographics, cancer type and treatment regimen. Statistical analysis will be descriptive and will be analyzed for each Biospecimen Source Site (BSS) as well as study aggregate.

  2. Percentage of enrolled patients by cancer type and treatment regimen overall [ Time Frame: Until completion of biospecimen collection, up to 3 years ]
    Will assess the percentage of enrolled patients by cancer type and treatment regimen overall and those who contribute samples to the Drug Resistance and Sensitivity Network and other approved investigators. Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate.

  3. Percentage of minority and underserved study participants accrued [ Time Frame: Until completion of biospecimen collection, up to 3 years ]
    Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate.


Secondary Outcome Measures :
  1. Pan-cancer gene panel tumor next generation sequencing test [ Time Frame: Until completion of biospecimen collection, up to 3 years ]
    Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate.

  2. Cancer Research Data Commons, The Cancer Imaging Archive and database of Genotypes and Phenotypes data contribution [ Time Frame: Until completion of biospecimen collection, up to 3 years ]
    Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate.

  3. Percentage of minority and underserved study participants accrued [ Time Frame: Until completion of biospecimen collection, up to 3 years ]
    Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate.

  4. Percentage of enrolled patients for whom molecular profiling is attempted [ Time Frame: Until completion of biospecimen collection, up to 3 years ]
    Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate. Will also be assessed by patient demographics, cancer type and treatment regimen.

  5. Percentage of enrolled patients for whom molecular profiling results are generated [ Time Frame: Until completion of biospecimen collection, up to 3 years ]
    Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate. Will also be assessed by patient demographics, cancer type and treatment regimen.

  6. Percentage of enrolled patients for whom samples are obtained at each longitudinal timepoint [ Time Frame: Until completion of biospecimen collection, up to 3 years ]
    Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate. Will also be assessed by patient demographics, cancer type and treatment regimen.

  7. Percentage of collected biospecimens that are delivered to the Patient Derived Models Repository [ Time Frame: Until completion of biospecimen collection, up to 3 years ]
    Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate. Will also be assessed by patient demographics, cancer type and treatment regimen.


Biospecimen Retention:   Samples With DNA
Blood, tissue, bone marrow, cerebral spinal fluid


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing treatment for cancer types with commercially available therapies.
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 castration-resistant prostate cancer
    • Gastroesophageal cancer: stage IV
    • Melanoma: clinical stage IV with pathologic stage III OR clinical stage 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 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, bone marrow 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
  • 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)

Exclusion Criteria:

  • 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
  • On chronic anticoagulation treatment that cannot be discontinued during the time interval necessary to undergo a biopsy
  • NCI PDMR EXCLUSION CRITERIA: Patients with CRC that is not mismatch repair deficient or microsatellite instability-high
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04314401


Locations
Show Show 98 study locations
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Helen M Moore National Cancer Institute (NCI)
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT04314401    
Other Study ID Numbers: NCI-2020-00750
NCI-2020-00750 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
10323 ( Other Identifier: National Cancer Institute )
10323 ( Other Identifier: CTEP )
First Posted: March 19, 2020    Key Record Dates
Last Update Posted: April 20, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page
URL: https://grants.nih.gov/policy/sharing.htm

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Lung Neoplasms
Prostatic Neoplasms
Colorectal Neoplasms
Melanoma
Adenocarcinoma
Skin Neoplasms
Esophageal Neoplasms
Multiple Myeloma
Carcinoma, Non-Small-Cell Lung
Carcinoma, Small Cell
Small Cell Lung Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Prostatic Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases