Concordance Between ctDNA Assay and FoundationOne

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.

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Key information

Conditions

Circulating Tumor DNA Cancer Genomic Alterations Genomic Testing Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Foundation Medicine

Cambridge, Massachusetts, 02141, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Foundation Medicine

Industry

Collaborators

Avera Cancer Institute
Comprehensive Blood and Cancer Center
Cone Health
Eastchester Center for Cancer Care
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
Prisma Health-Upstate
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

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Dec 3, 2015
Registry last updated: Aug 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed