Official Title
Study of Concordance Between Circulating Tumor DNA Assay and Foundation One Tissue Analysis For Genomic Alterations
Brief Title
Concordance Between ctDNA Assay and FoundationOne
Protocol ID
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.
Enrollment Count
1,400 participants
Eligibility Criteria
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).
Filters
Circulating Tumor DNA
Cancer
Neoplasms
Genomic Testing
Genomic Alterations
COMPLETED
ADULT
OLDER_ADULT