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Spots Global Cancer Trial Database for TCF-001 TRACK (Target Rare Cancer Knowledge) Study

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Trial Identification

Brief Title: TCF-001 TRACK (Target Rare Cancer Knowledge) Study

Official Title: TCF-001 TRACK (Target Rare Cancer Knowledge) Study

Study ID: NCT04504604

Study Description

Brief Summary: This open label, non-randomized, multi-center, pragmatic study aims to establish whether patients with rare tumors can benefit from matched molecular therapy as dictated by their next-generation sequencing (NGS) results.

Detailed Description: This open label, non-randomized, multi-center, pragmatic study aims to establish whether patients with rare tumors can benefit from matched molecular therapy as dictated by their next-generation sequencing (NGS) results. The study leverages a remote consent and participation approach to open enrollment to all patients with rare tumors within the United States. Traditional, site-based patient consenting and participation is also available for enrollment to the study. Each participant will undergo comprehensive genomic profiling (CGP) by Foundation Medicine Inc. (FMI) of their tumor as well as plasma circulating cell-free DNA. Plasma circulating cell-free DNA may be additionally collected for repeat CGP at various timepoints during the study. The CGP findings will be provided by FMI directly to the treating physician and study sponsor TargetCancer Foundation (TCF), with TCF presenting cases with genomic findings to the Virtual Molecular Tumor Board (VMTB). The VMTB will analyze the findings and provide a written report to the treating physician on recommended treatments and/or relevant clinical trials; the treating physician makes all treatment decisions. The resultant treatments and treatment responses will be tracked longitudinally during the term of this study, thus linking molecularly informed treatments to specific patient outcomes.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

TargetCancer Foundation, Cambridge, Massachusetts, United States

Contact Details

Name: Razelle Kurzrock, M.D.

Affiliation: Medical College of Wisconsin

Role: PRINCIPAL_INVESTIGATOR

Name: Vivek Subbiah, M.D.

Affiliation: SCRI Development Innovations, LLC

Role: PRINCIPAL_INVESTIGATOR

Name: Shumei Kato, M.D.

Affiliation: University of California, San Diego

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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