Concordance Between ctDNA Assay and FoundationOne

Completed

• Conditions: Circulating Tumor DNA; Neoplasms; Cancer; Genomic Testing; Genomic Alterations

• Registration Number: NCT02620527
• Lead Sponsor: Foundation Medicine

Brief Summary

Foundation Medicine Inc. (FMI) is interested in studying the concordance of genomic alterations between primary and/or metastatic surgical biopsies, and circulating tumor DNA (ctDNA) within different solid tumor types and has been developing an assay in order to do so.

Detailed Description

The purpose of this study is to assess whether a new ctDNA assay developed by Foundation Medicine is able to detect genomic alterations in peripheral blood that are consistent with the genomic alterations detected in a patient's matched primary and/or metastatic tumor biopsy sample analyzed by the FoundationOne® test. Study sites will provide matched solid tumor and peripheral blood samples of cancer patients to FMI for the purpose of testing the concordance of the FMI ctDNA assay to the FoundationOne® test. Participation in this study is part of a broader 2000 patient study to determine which tumor types are most readily measured via ctDNA profiling, and to learn of the similarity between the alterations found in a patient's tumor biopsy and the ctDNA from their blood.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-12-01
• Study First Submitted QC: 2015-12-01
• Study First Posted: 2015-12-03
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

• Patients who have had a solid tumor biopsy isolated for analysis by FoundationOne under their standard clinical care

Exclusion Criteria

• Tumor specimens where no cancer representative of the diagnosis is found in submitted tissue
• Tumor specimens where insufficient DNA (<50 ng) is provided to run the FoundationOne test.
• Tumor specimens with ≤20% tumor nuclei (all specimens).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine which tumor types are most amenable to detection using peripheral blood ctDNA assay	6-12 months
Whether new ctDNA assay can detect genomic alterations in peripheral blood that are consistent with those detected by FoundationOne in matched solid tumor samples	6-12 months

Trial Locations

Locations (1)

Foundation Medicine; 🇺🇸 Cambridge, Massachusetts, United States