NCT01464086CompletedPhase 3
LIFSCREEN : Evaluation of Whole Body MRI for Early Detection of Cancers in Subjects With P53 Mutation (Li-Fraumeni Syndrome)
Gustave Roussy, Cancer Campus, Grand Paris1 site in 1 country107 target enrollmentStarted: October 27, 2011Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 107
- Locations
- 1
- Primary Endpoint
- cancer incidence
Study Overview
Brief Summary
The purpose of this study is to compare the diagnostic efficacy of two follow-up schedules for the early detection of cancers in the population under study on cancer incidence at 3 years.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 5 Years to 71 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •P53 mutation
Exclusion Criteria
- Not provided
Arms & Interventions
Standard arm
No Intervention
standard follow-up
Intensive follow-up
Experimental
Standard follow-up plus whole body MRI at inclusion, one and two years
Intervention: whole body MRI (Other)
Outcomes
Primary Outcomes
cancer incidence
Time Frame: 3 years
cancer incidence during the first 3 years
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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