Trial record 4 of 28 for:    "Li Fraumeni syndrome"

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.
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
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 April 16, 2014