Magnetic Resonance Imaging Screening in Li Fraumeni Syndrome

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

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2017-12-31

Brief Summary

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This study is aimed at exploring the use of whole body MRI for early cancer detection in TP53 mutation carriers and population controls, with the hypothesis that more cancers will be detected in the TP53 mutation carrier group. A secondary end-point will be the number of incidental findings detected and subsequent investigations required. A series of questionnaires will be used to assess the psychological impact of screening on both the study and control group.

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Detailed Description

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Conditions

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Li-Fraumeni Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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TP53 mutation carriers

Carriers of TP53 mutation not known to be low penetrance

Whole body MRI

Intervention Type OTHER

Individuals will undergo whole body and brain MRI

Psychological questionnaires

Intervention Type OTHER

All recruits will complete questionnaires at 6 time points to assess psychological impact

Population controls

Population controls will be sex and aged matched (+/- 5 years) to the TP53 mutation carrier group, with no personal history of cancer and no family history of cancer diagnosed under 50 years

Whole body MRI

Intervention Type OTHER

Individuals will undergo whole body and brain MRI

Psychological questionnaires

Intervention Type OTHER

All recruits will complete questionnaires at 6 time points to assess psychological impact

Interventions

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Whole body MRI

Individuals will undergo whole body and brain MRI

Intervention Type OTHER

Psychological questionnaires

All recruits will complete questionnaires at 6 time points to assess psychological impact

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Carrier of germline TP53 mutation which, in the view of the geneticist, is not known to be low penetrance OR non-related individual with no personal history of malignancy and no first degree relatives diagnosed with malignancy under the age of 50 years
* Please note, TP53 carrier cohort is complete and no longer open to recruitment
* Age between 18 and 60
* Able to give informed consent

Exclusion Criteria

* Individual with low penetrance TP53 mutation
* Individual with TP53 variant of unknown significance.
* Previous malignancy diagnosed \< 5 years ago in TP53 carriers (except non-melanomatous skin cancer or cervical CIS) Previous history of malignancy in non-related controls (except non-melanomatous skin cancer or cervical CIS)
* Current symptoms suggestive of malignancy
* Contraindication to MRI (such as non-MR compatible metal implants) as specified by the standard MR safety checklist
* Claustrophobia
* ECOG performance status \>2

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes