Concordance Between ctDNA Assay and FoundationOne

Cancer Clinical Trial

Official title:

Study of Concordance Between Circulating Tumor DNA Assay and Foundation One Tissue Analysis For Genomic Alterations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02620527
• Other study ID #: FMI-CTDNA-15
• Status: Completed
• 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
• 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).

Related Conditions & MeSH terms

• Cancer
• Circulating Tumor DNA
• Genomic Alterations
• Genomic Testing
• Neoplasms

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