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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
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
Greenville Health System
Mary Crowley Cancer Research Center
Texas Health
University of California, San Diego
Avera Cancer Institute
Information provided by (Responsible Party):
Foundation Medicine

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 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



Primary Outcome Measures :
  1. 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 ]
  2. Determine which tumor types are most amenable to detection using peripheral blood ctDNA assay [ Time Frame: 6-12 months ]


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).

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
United States, Massachusetts
Foundation Medicine
Cambridge, Massachusetts, United States, 02141
Sponsors and Collaborators
Foundation Medicine
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
Greenville Health System
Mary Crowley Cancer Research Center
Texas Health
University of California, San Diego
Avera Cancer Institute
Investigators
Principal Investigator: Phil Stephens, PhD Foundation Medicine

Responsible Party: Foundation Medicine
ClinicalTrials.gov Identifier: NCT02620527     History of Changes
Other Study ID Numbers: FMI-CTDNA-15
First Posted: December 3, 2015    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018

Keywords provided by Foundation Medicine:
Circulating Tumor DNA
Cancer
Neoplasms
Genomic Testing
FoundationOne
Cell Free DNA
ctDNA
cfDNA