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
  Purpose

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.


Condition Intervention Phase
Li Fraumeni Syndrome
Other: whole body MRI
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • cancer incidence [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    cancer incidence during the first 3 years


Estimated Enrollment: 100
Study Start Date: September 2011
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard arm
standard follow-up
Experimental: Intensive follow-up
Standard follow-up plus whole body MRI at inclusion, one and two years
Other: whole body MRI
whole body MRI at inclusion, one and two years

  Eligibility

Ages Eligible for Study:   5 Years to 71 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • P53 mutation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01464086

Contacts
Contact: Olivier caron 33 1 42 11 51 78 olivier.caron@igr.fr

Locations
France
Institut Gustave Roussy Recruiting
Villejuif, France, 94805
Contact: Olivier caron    33 1 42 11 51 78      
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
  More Information

No publications provided

Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT01464086     History of Changes
Other Study ID Numbers: CSET2011/1748
Study First Received: October 31, 2011
Last Updated: January 16, 2014
Health Authority: France:AFSSAPS

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
patients with Li Fraumeni syndrome

Additional relevant MeSH terms:
Li-Fraumeni Syndrome
Neoplastic Syndromes, Hereditary
Neoplasms
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 20, 2014