An interventional study of Single Group Assignment in Adult Carriers of a Pathogenic or Probably Pathogenic (Class 4 and 5) Germline Variation in the TP53 Gene, sponsored by Gustave Roussy, Cancer Campus, Grand Paris. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Gustave Roussy, Cancer Campus, Grand Paris · Not applicable, Interventional, and Prevention
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
25 studies on the registry are indexed under Li-Fraumeni Syndrome; 16 are open to participants now.
Browse Li-Fraumeni Syndrome studies →Gustave Roussy, Cancer Campus, Grand Paris is the lead sponsor of 245 studies on the registry; 66 are open to participants now.
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Exclusion Criteria:
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.
Other: Single Group Assignment
Single Group Assignment
Change in the composite Lifestyle Index 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.
Time frame: From baseline to follow up visit at 1 year
Plan to share: No — 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.
No publications or documents are linked to this record.
Start is estimated for Feb 2027; primary completion for Mar 2027, 1 month later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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