Clinical trial NCT02620527: Concordance Between ctDNA Assay and FoundationOne
Official title: Study of Concordance Between Circulating Tumor DNA Assay and Foundation One Tissue Analysis For Genomic Alterations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Circulating Tumor DNA
Cancer
Neoplasms
Genomic Testing
Genomic Alterations
Keywords: Circulating Tumor DNA
Cancer
Neoplasms
Genomic Testing
FoundationOne
Cell Free DNA
ctDNA
cfDNA
Lead sponsor: Foundation Medicine
Sponsor class: INDUSTRY
Collaborators: name: Johns Hopkins University
name: Oncology Consultants
name: Comprehensive Blood and Cancer Center
name: Illinois CancerCare
name: Sanford Health
name: Eastchester Center for Cancer Care
name: Rutgers Cancer Institute of New Jersey
name: Cone Health
name: Nebraska Cancer Specialists
name: University of California, Davis
name: University of Chicago
name: Northeast Georgia Medical Center
name: Hematology Oncology Associates of Fredericksburg
name: Memorial Sloan Kettering Cancer Center
name: Oncology Hematology Care, Inc
name: Montefiore Medical Center
name: Quincy Medical Group
name: Prisma Health-Upstate
name: Mary Crowley Cancer Research Center
name: Texas Health
name: University of California, San Diego
name: Avera Cancer Institute
First posted: 2015-12-03
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with cancer and who have had a solid tumor biopsy isolated for analysis by FoundationOne

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.

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.

Eligibility 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).

Primary outcomes:
measure: Whether new ctDNA assay can detect genomic alterations in peripheral blood that are consistent with those detected by FoundationOne in matched solid tumor samples
timeFrame: 6-12 months
measure: Determine which tumor types are most amenable to detection using peripheral blood ctDNA assay
timeFrame: 6-12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Foundation Medicine
state: Massachusetts
Study officials:
affiliation: Foundation Medicine
name: Phil Stephens, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhou C, Yuan Z, Ma W, Qi L, Mahavongtrakul A, Li Y, Li H, Gong J, Fan RR, Li J, Molmen M, Clark TA, Pavlick D, Frampton GM, Forcier B, Moore EH, Shelton DK, Cooke M, Ali SM, Miller VA, Gregg JP, Stephens PJ, Li T. Clinical utility of tumor genomic profiling in patients with high plasma circulating tumor DNA burden or metabolically active tumors. J Hematol Oncol. 2018 Nov 6;11(1):129. doi: 10.1186/s13045-018-0671-8.