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

NCT ID: NCT01464086

Last Updated: 2021-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-27

Study Completion Date

2017-10-09

Brief Summary

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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

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Conditions

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Li Fraumeni Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Standard arm

standard follow-up

Group Type NO_INTERVENTION

No interventions assigned to this group

Intensive follow-up

Standard follow-up plus whole body MRI at inclusion, one and two years

Group Type EXPERIMENTAL

whole body MRI

Intervention Type OTHER

whole body MRI at inclusion, one and two years

Interventions

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whole body MRI

whole body MRI at inclusion, one and two years

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* P53 mutation
Minimum Eligible Age

5 Years

Maximum Eligible Age

71 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut Gustave Roussy

Villejuif, , France

Site Status

Countries

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France

References

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Caron O, Frebourg T, Benusiglio PR, Foulon S, Brugieres 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.

Reference Type DERIVED
PMID: 28772306 (View on PubMed)

Other Identifiers

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CSET2011/1748

Identifier Type: -

Identifier Source: org_study_id

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