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
18 Years
N/A
Both
Cancer, Neoplasm Metastasis, Tumor
Trial Information
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
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.
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
Type of Study:
Observational [Patient Registry]
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
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
Outcome Description:
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
Outcome Time Frame:
Minimum 1 year follow-up
Safety Issue:
No
Principal Investigator
Gary Palmer, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Sr VP Medical Afairs
Authority:
United States: Institutional Review Board
Study ID:
FMI-001-NGS-500
NCT ID:
NCT01851213
Start Date:
March 2013
Completion Date:
March 2015
Related Keywords:
- Cancer
- Neoplasm Metastasis
- Tumor
- genomics
- cancer
- registry
- neoplasm metastasis
- Neoplasms
- Neoplasm Metastasis
Name | Location |
|---|---|
| Evergreen Hematology/Oncology | Spokane, Washington 99218 |
