NCT06805734 Natural History With Focus on Oncological Risk Evaluation in Pediatric Patients With PTEN Pathogenic Variants
| NCT ID | NCT06805734 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta |
| Condition | PTEN Hamartoma Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2029-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2024-08-01 with a primary completion date of 2029-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is an observational study in pediatric patientis carryng PTEN pathogenic variants aimed to define oncological risk in children and provide a deeper insight of the clinical course, establishing an updated follow-up protocol.
Eligibility Criteria
Inclusion Criteria: * PTEN pathogenic variants (class 4/5 SNV, gene deletion, intragenic duplication/deletion) * Pediatric patients (\<18 years old) and their affected relatives, male/female, all ethnicities * The legal representative must agree to follow the screening protocol * Informed consent signed by the legal representative Exclusion Criteria: * Refuse to undergo the exams of the protocol assessment at the diagnosis * PTEN non-pathogenic variants (VOUS or benign/likely benign vatiants) * No signed informed consent
Frequently Asked Questions
Who can join the NCT06805734 clinical trial?
This trial is open to participants of all sexes, up to 17 Years, studying PTEN Hamartoma Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06805734 currently recruiting?
Yes, NCT06805734 is actively recruiting participants. Visit ClinicalTrials.gov or contact Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta to inquire about joining.
Where is the NCT06805734 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06805734 clinical trial?
NCT06805734 is sponsored by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta. The trial plans to enroll 50 participants.