Cancer, Circulating Tumor DNA, Genomic Alterations, Genomic Testing, Neoplasms
Conditions
Keywords
Circulating Tumor DNA, Cancer, Neoplasms, Genomic Testing, FoundationOne, Cell Free DNA, ctDNA, cfDNA
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.
Interventions
None listed
Sponsors
Johns Hopkins University
Oncology Consultants
Comprehensive Blood and Cancer Center
Illinois CancerCare
Sanford Health
Eastchester Center for Cancer Care
Rutgers Cancer Institute of New Jersey
Cone Health
Nebraska Cancer Specialists
University of California, Davis
University of Chicago
Northeast Georgia Medical Center
Hematology Oncology Associates of Fredericksburg
Memorial Sloan Kettering Cancer Center
Oncology Hematology Care, Inc
Montefiore Medical Center
Quincy Medical Group
Prisma Health-Upstate
Mary Crowley Cancer Research Center
Texas Health
University of California, San Diego
Avera Cancer Institute
Foundation Medicine
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| Determine which tumor types are most amenable to detection using peripheral blood ctDNA assay | 6-12 months |
Countries
United States
Outcome results
None listed