LIFSCREEN : Evaluation of Whole Body MRI for Early Detection of Cancers in Subjects With P53 Mutation (Li-Fraumeni Syndrome)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Gustave Roussy, Cancer Campus, Grand Paris
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT01464086
First received: October 31, 2011
Last updated: January 16, 2014
Last verified: January 2014

October 31, 2011
January 16, 2014
September 2011
February 2015   (final data collection date for primary outcome measure)
cancer incidence [ Time Frame: 3 years ] [ Designated as safety issue: No ]
cancer incidence during the first 3 years
Same as current
Complete list of historical versions of study NCT01464086 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
LIFSCREEN : Evaluation of Whole Body MRI for Early Detection of Cancers in Subjects With P53 Mutation (Li-Fraumeni Syndrome)
Not Provided

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Li Fraumeni Syndrome
Other: whole body MRI
whole body MRI at inclusion, one and two years
  • No Intervention: Standard arm
    standard follow-up
  • Experimental: Intensive follow-up
    Standard follow-up plus whole body MRI at inclusion, one and two years
    Intervention: Other: whole body MRI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
February 2018
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • P53 mutation
Both
5 Years to 71 Years
No
Contact: Olivier caron 33 1 42 11 51 78 olivier.caron@igr.fr
France
 
NCT01464086
CSET2011/1748
No
Gustave Roussy, Cancer Campus, Grand Paris
Gustave Roussy, Cancer Campus, Grand Paris
Not Provided
Not Provided
Gustave Roussy, Cancer Campus, Grand Paris
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP