FoundationOne™ Test Registry Study
Completed
Conditions studied: Cancer, Neoplasm Metastasis, Tumor
In brief
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.
Key facts
- Study ID
- NCT01851213
- Run by
- Foundation Medicine
- People needed
- 510
- Starts
- 2013-03-01
- Expected to finish
- 2016-03-01
- Last updated by the study team
- 2016-08-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- There are no exclusion criteria for this study
Where it is running
- Evergreen Hematology/Oncology — Spokane, Washington, United States
Full record on ClinicalTrials.gov
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