Back to resultsLIFSCREEN : Evaluation of Whole Body MRI for Early Detection of Cancers in Subjects With P53 Mutation (Li-Fraumeni Syndrome) (LIFSCREEN)
Primary Purpose
Li Fraumeni Syndrome
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
whole body MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Li Fraumeni Syndrome focused on measuring patients with Li Fraumeni syndrome
Eligibility Criteria
Inclusion Criteria:
- P53 mutation
Sites / Locations
- Institut Gustave Roussy
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard arm
Intensive follow-up
Arm Description
standard follow-up
Standard follow-up plus whole body MRI at inclusion, one and two years
Outcomes
Primary Outcome Measures
cancer incidence
cancer incidence during the first 3 years
Secondary Outcome Measures
Full Information
NCT ID
NCT01464086
First Posted
October 31, 2011
Last Updated
February 23, 2021
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
1. Study Identification
Unique Protocol Identification Number
NCT01464086
Brief Title
LIFSCREEN : Evaluation of Whole Body MRI for Early Detection of Cancers in Subjects With P53 Mutation (Li-Fraumeni Syndrome)
Acronym
LIFSCREEN
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 27, 2011 (Actual)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
October 9, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Li Fraumeni Syndrome
Keywords
patients with Li Fraumeni syndrome
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard arm
Arm Type
No Intervention
Arm Description
standard follow-up
Arm Title
Intensive follow-up
Arm Type
Experimental
Arm Description
Standard follow-up plus whole body MRI at inclusion, one and two years
Intervention Type
Other
Intervention Name(s)
whole body MRI
Intervention Description
whole body MRI at inclusion, one and two years
Primary Outcome Measure Information:
Title
cancer incidence
Description
cancer incidence during the first 3 years
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
71 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
P53 mutation
Facility Information:
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
28772306
Citation
Caron O, Frebourg T, Benusiglio PR, Foulon S, Brugieres L. Lung Adenocarcinoma as Part of the Li-Fraumeni Syndrome Spectrum: Preliminary Data of the LIFSCREEN Randomized Clinical Trial. JAMA Oncol. 2017 Dec 1;3(12):1736-1737. doi: 10.1001/jamaoncol.2017.1358.
Results Reference
derived
Learn more about this trial
LIFSCREEN : Evaluation of Whole Body MRI for Early Detection of Cancers in Subjects With P53 Mutation (Li-Fraumeni Syndrome)
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