TCF-001 TRACK (Target Rare Cancer Knowledge) Study
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- STATUS
- Recruiting
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- End date
- Dec 21, 2022
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- participants needed
- 400
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- sponsor
- TargetCancer Foundation
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.
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.
Details
| Condition | Malignant Adenoma, Neoplasms, Unknown Primary, Rare Cancers, Adenocarcinoma, Cholangiocarcinoma |
|---|---|
| Treatment | Foundation Medicine blood and tissue testing, FoundationOne CDx and FoundationOne Liquid CDx |
| Clinical Study Identifier | NCT04504604 |
| Sponsor | TargetCancer Foundation |
| Last Modified on | 21 October 2021 |
Eligibility
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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