Clinical trial · Observational
FoundationOne™ Test Registry Study
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- FoundationOne™ Test Ordered
- description
- Patients for whom a FoundationOne™ test was ordered and a report is delivered.
Primary outcomes (1)
- 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
- timeFrame
- Minimum 1 year follow-up
- 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
Secondary outcomes (1)
- measure
- Exploratory endpoints describing clinical outcomes in the study population
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available