Magnetic Resonance Imaging Screening in Li Fraumeni Syndrome | NCT01737255

Studies
Magnetic Resonance Imaging Screening in Li Fraumeni Syndrome

NCT01737255

Sponsor

Institute of Cancer Research, United Kingdom

Status

Completed

Last Update Posted

Mar 31, 2022Actual

Enrollment

88Actual

Phase

Not provided

Conditions

Li-Fraumeni Syndrome

Interventions

Whole body MRI
Psychological questionnaires

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Sep 2016Actual

Completion Date

Dec 2017Actual

First Submitted Date

Nov 27, 2012

First Submission Date that Met QC Criteria

Nov 27, 2012

First Posted Date

Nov 29, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2022

Last Update Posted Date

Mar 31, 2022Actual

Name	Class
Cancer Research UK	OTHER
National Institute for Health Research, United Kingdom	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

88Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TP53 mutation carriers		Carriers of TP53 mutation not known to be low penetrance	Other: Whole body MRI Other: Psychological questionnaires
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	Other: Whole body MRI Other: Psychological questionnaires

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Whole body MRI	Other	Individuals will undergo whole body and brain MRI	Population controls TP53 mutation carriers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnosis of malignant disease	Following MRI scan further investigations may be required to diagnose malignancy	Within 12 months of MRI scan

Secondary Outcomes

Measure	Description	Time Frame
Diagnosis of relevant non-malignant disease	Further investigations may be required following the MRI to characterise such findings.	12 months following MRI scan
Diagnosis of non-relevant disease, number and type of investigations required

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

The TP53 mutation carriers will be recruited from genetics clinics and through advertising.

The population controls will be recruited through advertising

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rosalind Eeles, PhD	Institute of Cancer Research, Surrey, UK	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cancer Genetics Unit, Royal Marsden Hospital		Sutton	Surrey	SM2 5PT	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Anonymised data can be applied for via the Steering Committee

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016864	Li-Fraumeni Syndrome

Ancestor Terms

ID	Term
D009386	Neoplastic Syndromes, Hereditary
D009369	Neoplasms
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided