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Trial Title:
Cancer Risk Assessment in Patients With a Constitutional Alteration of the PTEN Gene
NCT ID:
NCT05630105
Condition:
PTEN Gene Mutation
Conditions: Keywords:
PTEN gene mutation
risk of cancer occurence
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Summary:
This is a multicentric, observational, retrospective and prospective study, aiming to
estimate the risk of cancer occurrence in subjects carrying a PTEN mutation, based on the
constitution of a national cohort.
Detailed description:
After collection of the non objection and verification of the eligibility criteria, a
first clinical questionnaire will be completed by the participant and the prescribing
physician to collect the main medical events including the history of malignant tumor
pathologies until the date of inclusion in the study.
Thereafter, an annual questionnaire will be sent to the participants to update the
elements related to a tumor pathology.
For the case of patients who have died or been lost to follow-up, only the information
from the first clinical questionnaire will be collected from the data available from the
prescribing physician without informing the relatives. However, the investigating center
will have to check that these patients have not objected, during their lifetime, to the
use of their data.
Criteria for eligibility:
Study pop:
National observational cohort of participants identified as carriers of a constitutional
alteration of the PTEN gene identified and/or confirmed by the Bergonié Institute, the
national reference laboratory for the molecular diagnosis of Cowden's disease between
1997 and 2027.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Male or female.
2. Adult or child without age limit.
3. Carrier of a constitutional alteration of the PTEN gene established and/or confirmed
by the Institut Bergonié's genetics laboratory, following a request for molecular
diagnosis made between 1997 and 2027.
4. Participant informed of his genetic diagnosis.
5. Participant informed and not having expressed non-opposition to participate in the
research.
6. Participant affiliated to a French social security system in accordance with French
law on research involving the human person.
Exclusion Criteria:
1. Participant under guardianship or curatorship.
2. Persons deprived of their liberty by a judicial or administrative decision, persons
under psychiatric care, persons admitted to a health or social institution for
purposes other than research.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut Bergonié, Comprehensive Cancer Center
Address:
City:
Bordeaux
Country:
France
Status:
Recruiting
Start date:
February 7, 2023
Completion date:
January 2048
Lead sponsor:
Agency:
Institut Bergonié
Agency class:
Other
Source:
Institut Bergonié
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05630105
