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Clinical Trials/NCT01464086
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

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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