Adult Carriers of a Pathogenic or Probably Pathogenic (Class 4 and 5) Germline Variation in the TP53 GeneLIFPREVNCT07921537
Reduce All Avoidable Cancer-promoting Exposures in Individuals at High Genetic Risk of Cancer Carrying a Constitutional Variant of the TP53 Gene
A study testing Single Group Assignment in people with Adult Carriers of a Pathogenic or Probably Pathogenic (Class 4 and 5) Germline Variation in the TP53 Gene, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Carriers of a Pathogenic or Probably Pathogenic (Class 4 and 5) Germline Variation in the TP53 Gene
- What is being tested?
- Single Group Assignment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2027to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Gustave Roussy
Villejuif, 94805
Olivier CARON, MD, +33142115178, olivier.caron@gustaveroussy.fr
Tarek Ben-Ahmed, MD, +33142112612, tarek.ben-Ahmed@gustaveroussy.fr
About this study
Official title: 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.
Read more
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
- Being tested
- Single Group Assignment
- Keywords
- Li-Fraumeni syndrome, TP53, TP53 germline variant, Cancer prevention
- 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.
Single Group AssignmentOther
Single Group Assignment
| Study group | Role | What they receive |
|---|---|---|
| Single Group Assignment | Experimental | 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. Receives: Other: Single Group Assignment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to follow up visit at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study startFeb 2027 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Carriers of a Pathogenic or Probably Pathogenic (Class 4 and 5) Germline Variation in the TP53 GeneStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921537
- Sponsor's protocol ID
- 2025-A01242-47
- Other IDs
- CSET number 2026/4358
- Acronym
- LIFPREV
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07921537
- Acronym / sponsor ID
- LIFPREV / 2025-A01242-47
- Keywords
- Li-Fraumeni syndrome, TP53, TP53 germline variant, Cancer prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- Feb 2027 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 6 Nov 2026 (actual)
- 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group Assignment | Experimental | Other: Single Group AssignmentParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Single Group AssignmentSingle Group Assignment | Other | Single Group Assignment |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: 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.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Group Assignment in people with Adult Carriers of a Pathogenic or Probably Pathogenic (Class 4 and 5) Germline Variation in the TP53 Gene, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 6 Nov 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivier CARON, MD (+33142115178, olivier.caron@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the composite Lifestyle Index at 1 year (time frame: From baseline to follow up visit at 1 year). 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 6 Nov 2026.