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Magnetic Resonance Imaging Screening in Li Fraumeni Syndrome (SIGNIFY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01737255
Recruitment Status : Completed
First Posted : November 29, 2012
Last Update Posted : February 17, 2020
Sponsor:
Collaborators:
Cancer Research UK
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Institute of Cancer Research, United Kingdom

Study Description
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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.

Condition or disease Intervention/treatment
Li-Fraumeni Syndrome Other: Whole body MRI Other: Psychological questionnaires

Study Design
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Study Type : Observational
Actual Enrollment : 88 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Magnetic Resonance Imaging Screening In Li Fraumeni Syndrome: An Exploratory Whole Body MRI Study
Study Start Date : October 2012
Actual Primary Completion Date : September 2016
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Groups and Cohorts
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Group/Cohort Intervention/treatment
TP53 mutation carriers
Carriers of TP53 mutation not known to be low penetrance
 Other: Whole body MRI
Individuals will undergo whole body and brain MRI

Other: Psychological questionnaires
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
 Other: Whole body MRI
Individuals will undergo whole body and brain MRI

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


Outcome Measures
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Primary Outcome Measures :
  1. Diagnosis of malignant disease [ Time Frame: Within 12 months of MRI scan ]
    Following MRI scan further investigations may be required to diagnose malignancy


Secondary Outcome Measures :
  1. Diagnosis of relevant non-malignant disease [ Time Frame: 12 months following MRI scan ]
    Further investigations may be required following the MRI to characterise such findings.

  2. Diagnosis of non-relevant disease, number and type of investigations required [ Time Frame: 12 months following MRI ]
  3. Psychological impact of MRI screening [ Time Frame: 12 months following MRI screening ]
    Psychological questionnaires to be completed at intervals up till 12 months post scan


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

The population controls will be recruited through advertising

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01737255


Locations
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United Kingdom
Cancer Genetics Unit, Royal Marsden Hospital
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Cancer Research UK
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: Rosalind Eeles, PhD Institute of Cancer Research, Surrey, UK
More Information
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Responsible Party: Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier: NCT01737255    
Other Study ID Numbers: CCR3802
First Posted: November 29, 2012    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymised data can be applied for via the Steering Committee
Keywords provided by Institute of Cancer Research, United Kingdom:
Li-Fraumeni Syndrome
Whole Body Magnetic Resonance Imaging
TP53
Psychological Impact
Additional relevant MeSH terms:
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Li-Fraumeni Syndrome
Syndrome
Disease
Pathologic Processes
Neoplastic Syndromes, Hereditary
 Neoplasms
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases