Li-Fraumeni SyndromeSIGNIFYNCT01737255
Magnetic Resonance Imaging Screening in Li Fraumeni Syndrome
An observational study of Li-Fraumeni Syndrome, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Li-Fraumeni Syndrome
- What is being tested?
- Whole body MRI and Psychological questionnaires
- How many people
- 88 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2012to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The TP53 mutation carriers will be recruited from genetics clinics and through advertising. The population controls will be recruited through advertising
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cancer Genetics Unit, Royal Marsden Hospital
Sutton, Surrey, SM2 5PT
About this study
Official title: Magnetic Resonance Imaging Screening In Li Fraumeni Syndrome: An Exploratory Whole Body MRI Study
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.
- Conditions
- Li-Fraumeni Syndrome
- Being tested
- Whole body MRI, Psychological questionnaires
- Keywords
- Li-Fraumeni Syndrome, Whole Body Magnetic Resonance Imaging, TP53, Psychological Impact
- Medical subject headings
- Li-Fraumeni Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body MRIOther
Individuals will undergo whole body and brain MRI
Psychological questionnairesOther
All recruits will complete questionnaires at 6 time points to assess psychological impact
| Study group | Role | What they receive |
|---|---|---|
| TP53 mutation carriers | Carriers of TP53 mutation not known to be low penetrance Receives: 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 Receives: Other: Whole body MRI; Other: Psychological questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of malignant disease
Following MRI scan further investigations may be required to diagnose malignancy
Measured: Within 12 months of MRI scan
Secondary outcomes (3)
Diagnosis of relevant non-malignant disease
Further investigations may be required following the MRI to characterise such findings.
Measured: 12 months following MRI scan
Diagnosis of non-relevant disease, number and type of investigations required
Measured: 12 months following MRI
Psychological impact of MRI screening
Psychological questionnaires to be completed at intervals up till 12 months post scan
Measured: 12 months following MRI screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Li-Fraumeni SyndromeStudies of the same condition, open and under way.
- More trials run by Institute of Cancer Research, United KingdomThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Rosalind Eeles, PhD, Principal investigator, Institute of Cancer Research, Surrey, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737255
- Sponsor's protocol ID
- CCR3802
- Acronym
- SIGNIFY
- Status last verified
- Mar 2022
- First submitted
- 27 Nov 2012
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Anonymised data can be applied for via the Steering Committee
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging Screening In Li Fraumeni Syndrome: An Exploratory Whole Body MRI Study
- ClinicalTrials.gov ID
- NCT01737255
- Acronym / sponsor ID
- SIGNIFY / CCR3802
- Conditions
- Li-Fraumeni Syndrome
- Keywords
- Li-Fraumeni Syndrome, Whole Body Magnetic Resonance Imaging, TP53, Psychological Impact
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Collaborators
- Cancer Research UK, National Institute for Health Research, United Kingdom
- Study start
- Oct 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TP53 mutation carriers | – | Other: Whole body MRI, Other: Psychological questionnairesCarriers of TP53 mutation not known to be low penetrance |
| Population controls | – | Other: Whole body MRI, Other: Psychological questionnairesPopulation 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The TP53 mutation carriers will be recruited from genetics clinics and through advertising. The population controls will be recruited through advertising
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole body MRIIndividuals will undergo whole body and brain MRI | Other | Population controls, TP53 mutation carriers |
| Psychological questionnairesAll recruits will complete questionnaires at 6 time points to assess psychological impact | Other | Population controls, TP53 mutation carriers |
Primary outcome
Diagnosis of malignant disease
Time frame: Within 12 months of MRI scan
Following MRI scan further investigations may be required to diagnose malignancy
3 secondary outcomes
Diagnosis of relevant non-malignant disease
Time frame: 12 months following MRI scan
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: Yes. Anonymised data can be applied for via the Steering Committee
Related trials for Li-Fraumeni Syndrome
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Reduce All Avoidable Cancer-promoting Exposures in Individuals at High Genetic Risk of Cancer Carrying a Constitutional Variant of the TP53 Gene
Adult Carriers of a Pathogenic or Probably Pathogenic (Class 4 and 5) Germline Variation in the TP53 Gene
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Clinical and Genetic Studies of Li-Fraumeni Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosalind Eeles, PhD principal investigator
Institute of Cancer Research, Surrey, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Li-Fraumeni Syndrome, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of malignant disease (time frame: Within 12 months of MRI scan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.