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Magnetic Resonance Imaging Screening in Li Fraumeni Syndrome (SIGNIFY)

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ClinicalTrials.gov Identifier: NCT01737255
Recruitment Status : Completed
First Posted : November 29, 2012
Last Update Posted : March 6, 2019
Sponsor:
Collaborators:
Cancer Research UK
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Institute of Cancer Research, United Kingdom

Tracking Information
First Submitted Date November 27, 2012
First Posted Date November 29, 2012
Last Update Posted Date March 6, 2019
Study Start Date October 2012
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 27, 2012)
Diagnosis of malignant disease [ Time Frame: Within 12 months of MRI scan ]
Following MRI scan further investigations may be required to diagnose malignancy
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01737255 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 27, 2012)
  • 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.
  • Diagnosis of non-relevant disease, number and type of investigations required [ Time Frame: 12 months following MRI ]
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Magnetic Resonance Imaging Screening in Li Fraumeni Syndrome
Official Title Magnetic Resonance Imaging Screening In Li Fraumeni Syndrome: An Exploratory Whole Body MRI Study
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
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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

Condition Li-Fraumeni Syndrome
Intervention
  • 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
Study Groups/Cohorts
  • TP53 mutation carriers
    Carriers of TP53 mutation not known to be low penetrance
    Interventions:
    • 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
    Interventions:
    • Other: Whole body MRI
    • Other: Psychological questionnaires
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 27, 2012)
88
Original Estimated Enrollment Same as current
Actual Study Completion Date December 2017
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT01737255
Other Study ID Numbers CCR3802
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Anonymised data can be applied for via the Steering Committee
Responsible Party Institute of Cancer Research, United Kingdom
Study Sponsor Institute of Cancer Research, United Kingdom
Collaborators
  • Cancer Research UK
  • National Institute for Health Research, United Kingdom
Investigators
Principal Investigator: Rosalind Eeles, PhD Institute of Cancer Research, Surrey, UK
PRS Account Institute of Cancer Research, United Kingdom
Verification Date March 2019