FoundationOne™ Test Registry Study (FMI Registry)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01851213|
Recruitment Status : Completed
First Posted : May 10, 2013
Last Update Posted : August 9, 2016
|Condition or disease|
|Cancer Neoplasm Metastasis Tumor|
Molecular testing of tumors, using techniques such as next-generation sequencing (NGS), facilitates an individualized approach to cancer treatment by sub-classifying diseases on an individual basis. Physicians can utilize an in depth understanding of disease at a molecular level to optimize therapy by selecting the most appropriate drugs and therapeutic targets. Genomic profiling has identified multiple genomic aberrations that are predictive markers for treatment response with targeted therapeutics.
FoundationOne™ is a commercially available molecular diagnostics test, for all solid tumor types, that analyzes routine clinical specimens for somatic alterations in relevant cancer-related genes. This validated in vitro diagnostic test, is performed in a single Clinical Laboratory Improvement Amendments (CLIA) certified and College of American Pathologists (CAP) approved laboratory at Foundation Medicine, Inc. It provides individualized, potentially actionable information regarding a patient's molecular cancer subtype that can be used by physicians to tailor treatment options.
With the recent commercial availability of the FoundationOne™ test, knowledge gaps exist regarding practice patterns associated with the use of this test in routine clinical practice and the impact of this test on clinical decision making. There is limited information regarding physician and patient characteristics that determine which patients receive the test, rationale for patient selection, and how physicians interpret and use the test results. Findings from this study will help to optimize patient selection and maximize the clinical impact of the test in terms of guiding therapy.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||510 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||A Prospective Observational Study to Examine, in Routine Clinical Practice in the US, Practice Patterns and Impact on Clinical Decision Making Associated With the FoundationOne™ Next Generation Sequencing (NGS) Test|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||March 2016|
FoundationOne™ Test Ordered
Patients for whom a FoundationOne™ test was ordered and a report is delivered.
- Composite characterization of current real-world practice patterns in the use of the FoundationOne™ test and the effect of the FoundationOne™ test on clinical decision making across the US [ Time Frame: Minimum 1 year follow-up ]
Characterization of practice patterns for the use of the test described by:
- Provider and site characteristics of patients receiving the FoundationOne test
- Socio-demographic and clinical characteristics of patients receiving the FoundationOne test
Examination of the effect of the test on clinical decision making by describing:
- Subsequent treatment patterns for patients after receipt of test results
- Clinician report outcomes regarding how test results guided clinical decision making
- Exploratory endpoints describing clinical outcomes in the study population [ Time Frame: Minimum 1 year follow-up ]
- Overall survival
- 1-year survival
- Overall progression-free survival (PFS)
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): NCT01851213
|United States, Washington|
|Spokane, Washington, United States, 99218|
|Principal Investigator:||Gary Palmer, MD||Sr VP Medical Afairs|