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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date July 2018
Source Foundation Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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).

Study Design


Locations

Country Name City State
United States Foundation Medicine Cambridge Massachusetts

Sponsors (23)

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

Country where clinical trial is conducted

United States, 

Outcome

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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