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Active Not RecruitingNCT04314401

National Cancer Institute "Cancer Moonshot Biobank"

Cancer Moonshot Biobank Research Protocol

Status
Active Not Recruiting
Phase
—
Study type
Observational
Enrollment
1,600 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
13 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREBiospecimen CollectionUndergo collection of blood, tissue, bone marrow, and cerebral spinal fluid samples
PROCEDUREComputed TomographyUndergo CT
PROCEDUREMagnetic Resonance ImagingUndergo MRI
OTHERMedical Chart ReviewMedical charts are reviewed and data is collected
PROCEDUREParacentesisUndergo paracentesis
PROCEDUREPositron Emission TomographyUndergo PET/CT

Timeline

Start date
2020-11-11
Primary completion
2027-04-30
Completion
2027-04-30
First posted
2020-03-19
Last updated
2026-04-13

Locations

151 sites across 2 countries: United States, Puerto Rico

Source: ClinicalTrials.gov record NCT04314401. Inclusion in this directory is not an endorsement.