We are updating the design of this site. Learn more.
Show more
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)

This study is currently recruiting participants.
Verified February 2016 by Gustave Roussy, Cancer Campus, Grand Paris
Sponsor:
ClinicalTrials.gov Identifier:
NCT01464086
First Posted: November 3, 2011
Last Update Posted: February 10, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    cancer incidence during the first 3 years


Estimated Enrollment: 110
Study Start Date: September 2011
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (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

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, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • P53 mutation
  Contacts and Locations
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
  More Information

Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT01464086     History of Changes
Other Study ID Numbers: CSET2011/1748
First Submitted: October 31, 2011
First Posted: November 3, 2011
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