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

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ClinicalTrials.gov Identifier: NCT01464086
Recruitment Status : Completed
First Posted : November 3, 2011
Last Update Posted : February 25, 2021
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Actual Study Start Date : October 27, 2011
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : October 9, 2017

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



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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


Locations
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France
Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT01464086    
Other Study ID Numbers: CSET2011/1748
First Posted: November 3, 2011    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021
Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
patients with Li Fraumeni syndrome
Additional relevant MeSH terms:
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Li-Fraumeni Syndrome
Syndrome
Disease
Pathologic Processes
Neoplastic Syndromes, Hereditary
Neoplasms
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases