FoundationOne™ Test Registry Study
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/10/2016 |
| Start Date: | March 2013 |
| End Date: | March 2016 |
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
This study is a prospective, multicenter, observational study to characterize utilization
patterns of the FoundationOne™ test by oncologists under conditions of routine clinical
practice in the US. The study will also examine impact of test results on subsequent
clinical decisions regarding choice of therapy. The planned duration of the study is at
least 2 years with 1 year for patient recruitment and a minimum 1-year follow-up period for
each patient. Any patient for whom the treating physician has ordered a FoundationOne™ test
and a report is delivered is eligible for participation on the study. Eligible patients from
participating sites will be enrolled sequentially during the 1-year enrollment period. Sites
will be required to maintain an enrollment log of all patients for whom the FoundationOne™
test has been ordered and document patient disposition and reasons for non-participation.
All treatment decisions and clinical assessment will be made at the discretion of the
treating physician per usual care and are not mandated by study design or protocol. Informed
consent will be obtained from eligible patients prior to study entry.
patterns of the FoundationOne™ test by oncologists under conditions of routine clinical
practice in the US. The study will also examine impact of test results on subsequent
clinical decisions regarding choice of therapy. The planned duration of the study is at
least 2 years with 1 year for patient recruitment and a minimum 1-year follow-up period for
each patient. Any patient for whom the treating physician has ordered a FoundationOne™ test
and a report is delivered is eligible for participation on the study. Eligible patients from
participating sites will be enrolled sequentially during the 1-year enrollment period. Sites
will be required to maintain an enrollment log of all patients for whom the FoundationOne™
test has been ordered and document patient disposition and reasons for non-participation.
All treatment decisions and clinical assessment will be made at the discretion of the
treating physician per usual care and are not mandated by study design or protocol. Informed
consent will be obtained from eligible patients prior to study entry.
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.
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.
Inclusion Criteria:
The FoundationOne test was ordered by the treating physician under routine clinical
practice
- Age ≥ 18 years
- Patient willing and able to provide informed consent
- Informed consent date is at least one day prior to the FoundationOne test report date
Exclusion Criteria:
There are no exclusion criteria for this study
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