Li Fraumeni SyndromePhase 3LIFSCREENNCT01464086

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

A Phase 3 study testing whole body MRI in people with Li Fraumeni Syndrome, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 5 to 71 years
Conditions the study is for: Li Fraumeni Syndrome
What is being tested?: whole body MRI
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 107 participants
Where: 1 siteFrance
Study dates: 27 Oct 2011to 9 Oct 2017
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 71 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

P53 mutation

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

France1 site

Institut Gustave Roussy
Villejuif, 94805

Other trials in France

About this study

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.

Conditions: Li Fraumeni Syndrome
Being tested: whole body MRI
Keywords: patients with Li Fraumeni syndrome
Medical subject headings: Li-Fraumeni Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

whole body MRIOther
whole body MRI at inclusion, one and two years

Study groups in NCT01464086
Study group	Role	What they receive
Standard arm	No intervention	standard follow-up
Intensive follow-up	Experimental	Standard follow-up plus whole body MRI at inclusion, one and two years Receives: Other: whole body MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

cancer incidence
cancer incidence during the first 3 years
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Oct 20119 Oct 2017

First posted3 Nov 2011 (estimated)
Study start27 Oct 2011
Primary completion31 Mar 2017
Study completion9 Oct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Li Fraumeni SyndromeStudies of the same condition, open and under way.
More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 107 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01464086
Sponsor's protocol ID: CSET2011/1748
Acronym: LIFSCREEN
Status last verified: Feb 2021
First submitted: 31 Oct 2011
Last updated: 25 Feb 2021
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 28772306

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruiting
Reduce All Avoidable Cancer-promoting Exposures in Individuals at High Genetic Risk of Cancer Carrying a Constitutional Variant of the TP53 Gene
Adult Carriers of a Pathogenic or Probably Pathogenic (Class 4 and 5) Germline Variation in the TP53 Gene
RecruitingObservational study
Clinical and Genetic Studies of Li-Fraumeni Syndrome
Li-Fraumeni Syndrome, Neoplasms
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
RecruitingObservational study
CfDNA in Hereditary And High-risk Malignancies 2
Hereditary Cancer Syndrome

All Li Fraumeni Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: LIFSCREEN : Evaluation of Whole Body MRI for Early Detection of Cancers in Subjects With P53 Mutation (Li-Fraumeni Syndrome)
ClinicalTrials.gov ID: NCT01464086
Acronym / sponsor ID: LIFSCREEN / CSET2011/1748
Conditions: Li Fraumeni Syndrome
Keywords: patients with Li Fraumeni syndrome
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 107 participants (actual)
Lead sponsor: Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
Study start: 27 Oct 2011 (actual)
Primary completion: 31 Mar 2017 (actual)
Study completion: 9 Oct 2017 (actual)
First posted: 3 Nov 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Standard arm	No intervention	–standard follow-up
Intensive follow-up	Experimental	Other: whole body MRIStandard follow-up plus whole body MRI at inclusion, one and two years

Who may qualify

Ages: 5 to 71 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

P53 mutation

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
whole body MRIwhole body MRI at inclusion, one and two years	Other	Intensive follow-up

Primary outcome

cancer incidence
Time frame: 3 years
cancer incidence during the first 3 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
Derived from this study: PubMed 28772306Caron 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.

Related trials for Li Fraumeni Syndrome

Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruiting
Reduce All Avoidable Cancer-promoting Exposures in Individuals at High Genetic Risk of Cancer Carrying a Constitutional Variant of the TP53 Gene
Adult Carriers of a Pathogenic or Probably Pathogenic (Class 4 and 5) Germline Variation in the TP53 Gene
RecruitingObservational study
Clinical and Genetic Studies of Li-Fraumeni Syndrome
Li-Fraumeni Syndrome, Neoplasms
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
RecruitingObservational study
CfDNA in Hereditary And High-risk Malignancies 2
Hereditary Cancer Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing whole body MRI in people with Li Fraumeni Syndrome, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cancer incidence (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01464086, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.