NCT01464086

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2011

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 27, 2011

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 31, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 3, 2011

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2017

Completed
Last Updated

February 25, 2021

Status Verified

February 1, 2021

Enrollment Period

5.4 years

First QC Date

October 31, 2011

Last Update Submit

February 23, 2021

Conditions

Li Fraumeni Syndrome

Keywords

patients with Li Fraumeni syndrome

Outcome Measures

Primary Outcomes (1)

  • cancer incidence

    cancer incidence during the first 3 years

    3 years

Study Arms (2)

Standard arm

NO INTERVENTION

standard follow-up

Intensive follow-up

EXPERIMENTAL

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

Other: whole body MRI

Interventions

whole body MRIOTHER

whole body MRI at inclusion, one and two years

Intensive follow-up

Eligibility Criteria

Age5 Years - 71 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • P53 mutation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Gustave Roussy

Villejuif, 94805, France

Location

Related Publications (1)

  • 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.

    PMID: 28772306DERIVED

MeSH Terms

Conditions

Li-Fraumeni Syndrome

Condition Hierarchy (Ancestors)

Neoplastic Syndromes, HereditaryNeoplasmsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDNA Repair-Deficiency DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2011

First Posted

November 3, 2011

Study Start

October 27, 2011

Primary Completion

March 31, 2017

Study Completion

October 9, 2017

Last Updated

February 25, 2021

Record last verified: 2021-02

Locations

FR(1)