NCT06045702 Establishment of a Primary Epididymal Cell Model From Epididymal Samples to Study CFTR Gene Regulation
| NCT ID | NCT06045702 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Brest |
| Condition | Cystic Fibrosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-09-11 |
| Primary Completion | 2026-09-09 |
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 20 participants in total. It began in 2024-09-11 with a primary completion date of 2026-09-09.
⚠ 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
The aim of this observational study is to better understand the role and involvement of the regulatory elements of the CFTR gene, with the aim of better describing the 3D organisation of chromatin at the CFTR locus in epididymal cells in patients with male infertility of any kind, or with cystic fibrosis or bilateral agenesis of the vas deferens, requiring scheduled surgery. The main questions it aims to answer are: * to better characterise this 3D organisation of the CFTR locus, the study of regulatory elements in primary epididymal cells is the most relevant and realistic model. * to gain a better understanding of the regulation of the CFTR gene in epididymal cells in order to gain a better understanding of the pathology of male infertility caused by bilateral agenesis of the vas deferens, a symptom and also a borderline form of cystic fibrosis. Participants will Epididymal samples will be taken by a urologist for the AMP department during the planned surgery. The rest of the samples taken will be recovered for research purposes, with the aim of recovering the epididymal cells contained in the sample. This is in no way an additional procedure and will have no impact on the patient's health..
Eligibility Criteria
Inclusion Criteria: * Male patients over 18 years of age * Patients, without genetic pathology, scheduled for epididymal sampling surgery * Patients with cystic fibrosis or bilateral vas deferens agenesis, scheduled for epididymal sampling surgery. * Signature of a consent form Exclusion Criteria: * Patients not scheduled for epididymal harvesting surgery * Patients under legal protection (guardianship, curatorship) * Refusal to participate
Contact & Investigator
Antoine VALERI, MD,PhD
PRINCIPAL INVESTIGATOR
University Hospital, Brest
Frequently Asked Questions
Who can join the NCT06045702 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Cystic Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06045702 currently recruiting?
Yes, NCT06045702 is actively recruiting participants. Contact the research team at Antoine.Valeri@univ-brest.fr for enrollment information.
Where is the NCT06045702 trial being conducted?
This trial is being conducted at Brest, France.
Who is sponsoring the NCT06045702 clinical trial?
NCT06045702 is sponsored by University Hospital, Brest. The principal investigator is Antoine VALERI, MD,PhD at University Hospital, Brest. The trial plans to enroll 20 participants.