LIFSCREEN : Evaluation of Whole Body MRI for Early Detection of Cancers in Subjects With P53 Mutation (Li-Fraumeni Syndrome)
This study is currently recruiting participants.
Verified October 2011 by Institut Gustave Roussy
Sponsor:
Institut Gustave Roussy
Information provided by (Responsible Party):
Institut Gustave Roussy
ClinicalTrials.gov Identifier:
NCT01464086
First received: October 31, 2011
Last updated: November 2, 2011
Last verified: October 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
Resource links provided by NLM:
Genetics Home Reference related topics:
Li-Fraumeni syndrome
MedlinePlus related topics:
Cancer
U.S. FDA Resources
Further study details as provided by Institut Gustave Roussy:
Primary Outcome Measures:
- cancer incidence [ Time Frame: 3 years ] [ Designated as safety issue: No ]cancer incidence during the first 3 years
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | October 2016 |
| Estimated Primary Completion Date: | October 2013 (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| Ages Eligible for Study: | 5 Years to 71 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- P53 mutation
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
Institut Gustave Roussy
More Information
No publications provided
| Responsible Party: | Institut Gustave Roussy |
| ClinicalTrials.gov Identifier: | NCT01464086 History of Changes |
| Other Study ID Numbers: | CSET2011/1748 |
| Study First Received: | October 31, 2011 |
| Last Updated: | November 2, 2011 |
| Health Authority: | France:AFSSAPS |
Keywords provided by Institut Gustave Roussy:
|
patients with Li Fraumeni syndrome |
Additional relevant MeSH terms:
|
Li-Fraumeni Syndrome Neoplastic Syndromes, Hereditary Neoplasms |
Genetic Diseases, Inborn DNA Repair-Deficiency Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013