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.
Brief Title
Concordance Between ctDNA Assay and FoundationOne
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Circulating Tumor DNA
Cancer
Neoplasms
Genomic Testing
Genomic Alterations
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).
* 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).
Inclusion Criteria
Inclusion Criteria:
* Patients who have had a solid tumor biopsy isolated for analysis by FoundationOne under their standard clinical care
* Patients who have had a solid tumor biopsy isolated for analysis by FoundationOne under their standard clinical care
Gender
All
Gender Based
false
Keywords
Circulating Tumor DNA
Cancer
Neoplasms
Genomic Testing
FoundationOne
Cell Free DNA
ctDNA
cfDNA
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02620527
Org Class
Industry
Org Full Name
Foundation Medicine
Org Study Id
FMI-CTDNA-15
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Study of Concordance Between Circulating Tumor DNA Assay and Foundation One Tissue Analysis For Genomic Alterations
Primary Outcomes
Outcome Measure
Whether new ctDNA assay can detect genomic alterations in peripheral blood that are consistent with those detected by FoundationOne in matched solid tumor samples
Outcome Time Frame
6-12 months
Outcome Measure
Determine which tumor types are most amenable to detection using peripheral blood ctDNA assay
Outcome Time Frame
6-12 months
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Patients diagnosed with cancer and who have had a solid tumor biopsy isolated for analysis by FoundationOne
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Haiying Cheng
Investigator Email
HCHENG@montefiore.org
Investigator Phone
718-405-8404
Categories Mesh Debug
Cancer --- NEOPLASMS
MeSH Terms
NEOPLASMS