ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01464086
Recruitment Status : Unknown
Verified February 2016 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was:  Recruiting
First Posted : November 3, 2011
Last Update Posted : February 10, 2016
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

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.

Condition or disease Intervention/treatment Phase
Li Fraumeni Syndrome Other: whole body MRI Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : September 2011
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. cancer incidence [ Time Frame: 3 years ]
    cancer incidence during the first 3 years



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   5 Years to 71 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • P53 mutation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT01464086     History of Changes
Other Study ID Numbers: CSET2011/1748
First Posted: November 3, 2011    Key Record Dates
Last Update Posted: February 10, 2016
Last Verified: February 2016

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

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