Concordance Between ctDNA Assay and FoundationOne
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/3/2018 |
| Start Date: | November 2014 |
| End Date: | December 2017 |
Study of Concordance Between Circulating Tumor DNA Assay and Foundation One Tissue Analysis For Genomic Alterations
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.
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.
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.
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.
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).
We found this trial at
1
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