Concordance Between ctDNA Assay and FoundationOne

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ClinicalTrials.gov Identifier: NCT02620527

Recruitment Status : Completed

First Posted : December 3, 2015

Last Update Posted : August 1, 2018

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

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

Information provided by (Responsible Party):

Foundation Medicine

Study Description

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.

Condition or disease
Circulating Tumor DNA Cancer Neoplasms Genomic Testing Genomic Alterations

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.

Study Design

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Study Type :	Observational
Actual Enrollment :	1400 participants
Observational Model:	Other
Time Perspective:	Other
Official Title:	Study of Concordance Between Circulating Tumor DNA Assay and Foundation One Tissue Analysis For Genomic Alterations
Study Start Date :	November 2014
Actual Primary Completion Date :	December 2017
Actual Study Completion Date :	December 2017

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

Whether new ctDNA assay can detect genomic alterations in peripheral blood that are consistent with those detected by FoundationOne in matched solid tumor samples [ Time Frame: 6-12 months ]
Determine which tumor types are most amenable to detection using peripheral blood ctDNA assay [ Time Frame: 6-12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients diagnosed with cancer and who have had a solid tumor biopsy isolated for analysis by FoundationOne

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).

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02620527

Locations

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United States, Massachusetts
Foundation Medicine
Cambridge, Massachusetts, United States, 02141

Sponsors and Collaborators