Cancer Clinical Trial
Official title:
Study of Concordance Between Circulating Tumor DNA Assay and Foundation One Tissue Analysis For Genomic Alterations
NCT number | NCT02620527 |
Other study ID # | FMI-CTDNA-15 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 2014 |
Est. completion date | December 2017 |
Verified date | July 2018 |
Source | Foundation Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1400 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
United States | Foundation Medicine | Cambridge | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Foundation Medicine | Avera Cancer Institute, Comprehensive Blood and Cancer Center, Cone Health, Eastchester Center for Cancer Care, Greenville Health System, Hematology Oncology Associates of Fredericksburg, Illinois CancerCare, Johns Hopkins University, Mary Crowley Cancer Research Center, Memorial Sloan Kettering Cancer Center, Montefiore Medical Center, Nebraska Cancer Specialists, Northeast Georgia Medical Center, Oncology Consultants, Oncology Hematology Care, Inc, Quincy Medical Group, Rutgers Cancer Institute of New Jersey, Sanford Health, Texas Health, University of California, Davis, University of California, San Diego, University of Chicago |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | ||
Primary | Determine which tumor types are most amenable to detection using peripheral blood ctDNA assay | 6-12 months |
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