Reduce All Avoidable Cancer-promoting Exposures in Individuals at High Genetic Risk of Cancer Carrying a Constitutional Variant of the TP53 Gene (LIFPREV)
Personalized Intervention to Reduce All Avoidable Cancer-promoting Exposures in Individuals at High Genetic Risk of Cancer Carrying a Constitutional Variant of the TP53 Gene
45% of cancer deaths are linked to modifiable factors (behavioral, metabolic). Li-Fraumeni syndrome (LFS), caused by germline TP53 mutations, leads to an extremely high, early-onset cancer risk (≈24× higher than general population).
Current surveillance programs are intensive but show no clear survival benefit; primary prevention is minimal.
Evidence suggests health behaviors (smoking, alcohol, diet, weight, physical activity) may influence cancer risk in TP53 carriers.
Early studies show frequent modifiable risk factors in this population (smoking, overweight/obesity, poor diet).
A major unmet need appears: current LFS care is currently focused almost solely on screening, without any other prevention measures.
This study aims to evaluate this participatory, multidimensional prevention program for germline TP53 carriers. If effective, it could be scaled nationally and internationally
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Olivier CARON, MD
- Phone Number: +33142115178
- Email: olivier.caron@gustaveroussy.fr
Study Contact Backup
- Name: Tarek Ben-Ahmed, MD
- Phone Number: +33142112612
- Email: tarek.ben-Ahmed@gustaveroussy.fr
Study Locations
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-
-
Villejuif, France, 94805
- Gustave Roussy
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Contact:
- Olivier CARON, MD
- Phone Number: +33142115178
- Email: olivier.caron@gustaveroussy.fr
-
Contact:
- Tarek Ben-Ahmed, MD
- Phone Number: +33142112612
- Email: tarek.ben-Ahmed@gustaveroussy.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult carriers of a pathogenic or likely pathogenic (class 4 or 5) germline variant in the TP53 gene.
- Free of active cancer, defined as cancer-free or having received no cancer treatment for more than one year, except hormone therapy for breast or prostate cancer.
- Attending the INTERCEPTION One-stop Prevention Clinic (OPC).
- Able to read and understand French.
- Agree to use their smartphone, including installation/use of the MyINTERCEPTION application and scanning QR codes to access study questionnaires.
Exclusion Criteria:
- Persons under guardianship or curatorship.
- Persons with currently active cancer or malignant disease.
- Persons currently receiving chemotherapy, radiotherapy, or targeted therapy for cancer. Hormone therapy for breast or prostate cancer is permitted.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Single Group Assignment
Participants will receive a personalized, multidimensional cancer prevention intervention integrated into the INTERCEPTION program, including assessment of modifiable cancer risk factors, educational and individualized counseling, a personalized prevention plan, digital follow-up through MyINTERCEPTION, and motivational telecoaching. |
Single Group Assignment |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the composite Lifestyle Index at 1 year
Time Frame: From baseline to follow up visit at 1 year
|
Percentage of participants who achieve an improvement of at least 1 point in the composite Lifestyle Index between baseline and the 1-year follow-up visit (V2). The Lifestyle Index assesses exposure to modifiable cancer risk factors and is based on the World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) cancer prevention recommendations. |
From baseline to follow up visit at 1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-A01242-47
- CSET number 2026/4358 (Other Identifier: Gustave Roussy)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Individual participant data (IPD) will not be made publicly available. Study data will be pseudonymized and access will be restricted to authorized members of the study team in accordance with applicable data protection requirements.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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