National Cancer Institute "Cancer Moonshot Biobank"

Multiple Myeloma Clinical Trial

Official title: Cancer Moonshot Biobank Research Protocol

Status Recruiting

Clinical Trial 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.

Clinical Trial 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), 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, post 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 5 years. ;

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Adenocarcinoma
• Anatomic Stage III Breast Cancer AJCC v8
• Anatomic Stage IV Breast Cancer AJCC v8
• Breast Neoplasms
• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Ovarian Epithelial
• Carcinoma, Small Cell
• Clinical Stage III Cutaneous Melanoma AJCC v8
• Clinical Stage IV Cutaneous Melanoma AJCC v8
• Clinical Stage IV Esophageal Adenocarcinoma AJCC v8
• Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8
• Clinical Stage IV Gastric Cancer AJCC v8
• Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
• Esophageal Squamous Cell Carcinoma
• Lung Neoplasms
• Lung Non-Small Cell Carcinoma
• Lung Small Cell Carcinoma
• Malignant Solid Neoplasm
• Melanoma
• Metastatic Prostate Carcinoma
• Multiple Myeloma
• Ovarian Neoplasms
• Prostatic Neoplasms
• Skin Neoplasms
• Small Cell Lung Carcinoma
• Stage III Lung Cancer AJCC v8
• Stage III Ovarian Cancer AJCC v8
• Stage IV Colorectal Cancer AJCC v8
• Stage IV Lung Cancer AJCC v8
• Stage IV Ovarian Cancer AJCC v8
• Stage IV Prostate Cancer AJCC v8
• Stage IVB Prostate Cancer AJCC v8

• NCT number: NCT04314401
• Study type: Observational
• Source: National Cancer Institute (NCI)
• Status: Recruiting
• Start date: November 11, 2020
• Completion date: September 16, 2025