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

• ClinicalTrials.gov Identifier: NCT01464086
• Recruitment Status: Unknown
• First Posted: November 3, 2011
• Last Update Posted: February 10, 2016
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Information provided by (Responsible Party): Gustave Roussy, Cancer Campus, Grand Paris

Tracking Information

• First Submitted Date: October 31, 2011
• First Posted Date: November 3, 2011
• Last Update Posted Date: February 10, 2016
• Study Start Date: September 2011
• Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 2, 2011)

cancer incidence [ Time Frame: 3 years ]

cancer incidence during the first 3 years

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: LIFSCREEN : Evaluation of Whole Body MRI for Early Detection of Cancers in Subjects With P53 Mutation (Li-Fraumeni Syndrome)
• Official Title: Not Provided
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Li Fraumeni Syndrome

Intervention

Other: whole body MRI

whole body MRI at inclusion, one and two years

Study Arms

• No Intervention: Standard arm
  standard follow-up
• Experimental: Intensive follow-up
  Standard follow-up plus whole body MRI at inclusion, one and two years
  Intervention: Other: whole body MRI

• Publications *: Caron O, Frebourg T, Benusiglio PR, Foulon S, Brugières L. Lung Adenocarcinoma as Part of the Li-Fraumeni Syndrome Spectrum: Preliminary Data of the LIFSCREEN Randomized Clinical Trial. JAMA Oncol. 2017 Dec 1;3(12):1736-1737. doi: 10.1001/jamaoncol.2017.1358.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 9, 2016): 110
• Original Estimated Enrollment (submitted: November 2, 2011): 100
• Estimated Study Completion Date: March 2018
• Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• P53 mutation

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 5 Years to 71 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01464086
• Other Study ID Numbers: CSET2011/1748
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
• Study Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Gustave Roussy, Cancer Campus, Grand Paris
• Verification Date: February 2016