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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Olivier CARON, MD
- Telefonnummer: +33142115178
- E-mail: olivier.caron@gustaveroussy.fr
Undersøgelse Kontakt Backup
- Navn: Tarek Ben-Ahmed, MD
- Telefonnummer: +33142112612
- E-mail: tarek.ben-Ahmed@gustaveroussy.fr
Studiesteder
-
-
-
Villejuif, Frankrig, 94805
- Gustave Roussy
-
Kontakt:
- Olivier CARON, MD
- Telefonnummer: +33142115178
- E-mail: olivier.caron@gustaveroussy.fr
-
Kontakt:
- Tarek Ben-Ahmed, MD
- Telefonnummer: +33142112612
- E-mail: tarek.ben-Ahmed@gustaveroussy.fr
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in the composite Lifestyle Index at 1 year
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2025-A01242-47
- CSET number 2026/4358 (Anden identifikator: Gustave Roussy)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .