Cancer Moonshot Biobank Research Protocol
Overview
- Phase
- N/A
- Intervention
- Biospecimen Collection
- Conditions
- Not specified
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 1600
- Locations
- 434
- Primary Endpoint
- Procure, store and distribute longitudinal biospecimens and associated clinical data
- Status
- Active, Not Recruiting
- Last Updated
- 19 days ago
Overview
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.
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 and other National Clinical Trials Network (NCTN) 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 up to 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) and other potential NCI databases, 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 samples during baseline and at time of disease progression and collection of blood samples throughout the study, including at time of 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. Additionally, patients may undergo computed tomography (CT), positron emission tomography (PET)/CT and/or magnetic resonance imaging (MRI) throughout the study, and may undergo paracentesis on study. Patient medical records are reviewed, and data is collected for at least 5 years.
Investigators
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
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
Arms & Interventions
Observational (biospecimen collection, chart review)
Patients undergo collection of tissue samples during baseline and at time of disease progression and collection of blood samples throughout the study, including at time of 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. Additionally, patients may undergo CT, PET/CT and/or MRI throughout the study, and may undergo paracentesis on study. Patient medical records are reviewed, and data is collected for at least 5 years.
Intervention: Biospecimen Collection
Observational (biospecimen collection, chart review)
Patients undergo collection of tissue samples during baseline and at time of disease progression and collection of blood samples throughout the study, including at time of 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. Additionally, patients may undergo CT, PET/CT and/or MRI throughout the study, and may undergo paracentesis on study. Patient medical records are reviewed, and data is collected for at least 5 years.
Intervention: Paracentesis
Observational (biospecimen collection, chart review)
Patients undergo collection of tissue samples during baseline and at time of disease progression and collection of blood samples throughout the study, including at time of 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. Additionally, patients may undergo CT, PET/CT and/or MRI throughout the study, and may undergo paracentesis on study. Patient medical records are reviewed, and data is collected for at least 5 years.
Intervention: Medical Chart Review
Observational (biospecimen collection, chart review)
Patients undergo collection of tissue samples during baseline and at time of disease progression and collection of blood samples throughout the study, including at time of 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. Additionally, patients may undergo CT, PET/CT and/or MRI throughout the study, and may undergo paracentesis on study. Patient medical records are reviewed, and data is collected for at least 5 years.
Intervention: Computed Tomography
Observational (biospecimen collection, chart review)
Patients undergo collection of tissue samples during baseline and at time of disease progression and collection of blood samples throughout the study, including at time of 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. Additionally, patients may undergo CT, PET/CT and/or MRI throughout the study, and may undergo paracentesis on study. Patient medical records are reviewed, and data is collected for at least 5 years.
Intervention: Positron Emission Tomography
Observational (biospecimen collection, chart review)
Patients undergo collection of tissue samples during baseline and at time of disease progression and collection of blood samples throughout the study, including at time of 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. Additionally, patients may undergo CT, PET/CT and/or MRI throughout the study, and may undergo paracentesis on study. Patient medical records are reviewed, and data is collected for at least 5 years.
Intervention: Magnetic Resonance Imaging
Outcomes
Primary Outcomes
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.
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.
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 Outcomes
- Pan-cancer gene panel tumor next generation sequencing test(Until completion of biospecimen collection, up to 3 years)
- Percentage of enrolled patients for whom molecular profiling is attempted(Until completion of biospecimen collection, up to 3 years)
- Percentage of enrolled patients for whom molecular profiling results are generated(Until completion of biospecimen collection, up to 3 years)
- Cancer Research Data Commons, The Cancer Imaging Archive and database of Genotypes and Phenotypes data contribution(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)
- Percentage of enrolled patients for whom samples are obtained at each longitudinal timepoint(Until completion of biospecimen collection, up to 3 years)
- Percentage of collected biospecimens that are delivered to the Patient Derived Models Repository(Until completion of biospecimen collection, up to 3 years)