- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01464086
LIFSCREEN : Evaluation of Whole Body MRI for Early Detection of Cancers in Subjects With P53 Mutation (Li-Fraumeni Syndrome) (LIFSCREEN)
February 23, 2021 updated by: Gustave Roussy, Cancer Campus, Grand Paris
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
107
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Villejuif, France, 94805
- Institut Gustave Roussy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 71 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- P53 mutation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
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whole body MRI at inclusion, one and two years
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cancer incidence
Time Frame: 3 years
|
cancer incidence during the first 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 27, 2011
Primary Completion (Actual)
March 31, 2017
Study Completion (Actual)
October 9, 2017
Study Registration Dates
First Submitted
October 31, 2011
First Submitted That Met QC Criteria
November 2, 2011
First Posted (Estimate)
November 3, 2011
Study Record Updates
Last Update Posted (Actual)
February 25, 2021
Last Update Submitted That Met QC Criteria
February 23, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSET2011/1748
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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