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National Cancer Institute "Cancer Moonshot Biobank"

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ClinicalTrials.gov Identifier: NCT04314401
Recruitment Status : Recruiting
First Posted : March 19, 2020
Last Update Posted : March 5, 2021
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
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 Hematopoietic and Lymphoid Cell Neoplasm 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 Refractory 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 a molecular profiling assay 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: 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:

  • Patient diagnosed with Stage IV colorectal cancer, Stage III/IV non-small cell or small cell lung cancer, metastatic castration-resistant prostate cancer, stage IV gastroesophageal cancer, stage III/IV melanoma, or treatment refractory multiple myeloma, is undergoing first or subsequent lines of standard of care therapy per National Comprehensive Cancer Network (NCCN) guidelines and has consented to provide longitudinal biospecimens
  • Patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 may be enrolled retrospectively (i.e. at time of progression) if archival material is submitted that contains the cancer type for which the participant is enrolled and that was collected up to 5 years prior to initiation of a therapy, assuming that no more than 1 line of intervening standard of care systemic therapy was administered from the date of archival material collection to the date of initiation of therapy. Patients with a PS of 2 may be enrolled only at the discretion of the treating physician and radiologist
  • Age 13 or older, any sex and any gender may be enrolled, but participants under the age of majority will only contribute biospecimens from procedures that are scheduled due to medical necessity and not for the sole purpose of collecting samples for this study
  • Patients must have tumor amenable to image guided or direct vision biopsy and be willing and able to undergo a tumor biopsy for molecular profiling. The biopsy must not be associated with a significant risk of severe or major complications or death. In particular, endoscopic, open or laparoscopic surgical procedures are not to be performed to provide research biospecimens. However, research biospecimens may be provided if the patient needs to undergo such procedures for clinical reasons. Severe or major complications are considered to be those:

    • Requiring therapy, minor hospitalization (more than overnight but < 48 hours [h]).
    • Requiring major therapy; unplanned increase in level of care, prolonged hospitalization > 48 h.
    • Resulting in permanent adverse sequelae
    • Resulting in death
    • The following tumors may be collected only when patients will be undergoing a procedure due to medical necessity during which the tissue may be collected and not for the sole purpose of the clinical study:

      • Brain biopsies: ONLY if the patient has medical necessity for craniotomy for clinical care
      • Mediastinal, laparoscopic, gastrointestinal, or bronchial endoscopic biopsies: ONLY to be obtained incidentally to a clinically necessary procedure
  • Study participants with lung cancer (LCA), colorectal cancer (CRC), prostate cancer (PCA), gastroesophageal cancer (GEC), melanoma (MEL), and multiple myeloma (MML) may contribute samples for Patient Derived Models (PDM) development if they meet specific Patient Derived Models Repository (PDMR) eligibility criteria
  • To ensure that individuals who experience diminished decision making capacity during the course of their cancer treatment are eligible, consent may be provided by a legally authorized representative (LAR) in accordance with 45 Code of Federal Regulations (CFR) 46.102(i). This protocol is minimal risk
  • NCI PDMR INCLUSION CRITERIA: Baseline and progression timepoints
  • NCI PDMR INCLUSION CRITERIA: CRC must be mismatch repair deficient and/or microsatellite instability-high

Exclusion Criteria:

  • Patients who are currently or have previously enrolled in an oncology interventional clinical trial
  • Uncontrolled intercurrent illness that in the physician's assessment would pose undue risk for biopsy
  • If the patient is on chronic anticoagulation treatment, they must be able and willing to have this treatment discontinued for the biopsy. Discontinuation procedures will be those of the treating site
  • Patients with CRC, LCA, PCA, GEC and MEL who are being evaluated at NCORP sites that are currently participating in the NCORP Tissue Procurement Protocol #10231
  • 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
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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: March 5, 2021
Last Verified: January 2021
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
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
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