Trial record 2 of 30 for:    "Li Fraumeni syndrome"

Magnetic Resonance Imaging Screening in Li Fraumeni Syndrome (SIGNIFY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Institute of Cancer Research, United Kingdom
Sponsor:
Collaborators:
Cancer Research UK
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier:
NCT01737255
First received: November 27, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

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 Intervention
Li-Fraumeni Syndrome
Other: Whole body MRI
Other: Psychological questionnaires

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Magnetic Resonance Imaging Screening In Li Fraumeni Syndrome: An Exploratory Whole Body MRI Study

Resource links provided by NLM:


Further study details as provided by Institute of Cancer Research, United Kingdom:

Primary Outcome Measures:
  • Diagnosis of malignant disease [ Time Frame: Within 12 months of MRI scan ] [ Designated as safety issue: No ]
    Following MRI scan further investigations may be required to diagnose malignancy


Secondary Outcome Measures:
  • Diagnosis of relevant non-malignant disease [ Time Frame: 12 months following MRI scan ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Psychological impact of MRI screening [ Time Frame: 12 months following MRI screening ] [ Designated as safety issue: No ]
    Psychological questionnaires to be completed at intervals up till 12 months post scan


Estimated Enrollment: 88
Study Start Date: October 2012
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01737255

Contacts
Contact: Rosalind Eeles, PhD 44 208 661 3642 rosalind.eeles@icr.ac.uk
Contact: Emma Killick, MBBS 44 208 661 3375 emma.killick@icr.ac.uk

Locations
United Kingdom
Cancer Genetics Unit, Royal Marsden Hospital Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Rosalind A Eeles, FRCP FRCR    44 208 661 3642    rosalind.eeles@icr.ac.uk   
Contact: Elizabeth K Bancroft, RGN MMedSci    44 207 808 2136    elizabeth.bancroft@icr.ac.uk   
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Cancer Research UK
National Institute for Health Research, United Kingdom
Investigators
Principal Investigator: Rosalind Eeles, PhD Institute of Cancer Research, Surrey, UK
  More Information

No publications provided

Responsible Party: Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier: NCT01737255     History of Changes
Other Study ID Numbers: CCR3802
Study First Received: November 27, 2012
Last Updated: November 27, 2012
Health Authority: United Kingdom: NHS Health Research Authority

Keywords provided by Institute of Cancer Research, United Kingdom:
Li-Fraumeni Syndrome
Whole Body Magnetic Resonance Imaging
TP53
Psychological Impact

Additional relevant MeSH terms:
Syndrome
Li-Fraumeni Syndrome
Disease
Pathologic Processes
Neoplastic Syndromes, Hereditary
Neoplasms
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 16, 2014