Building primary epididymal cell models to look at CFTR gene regulation
Establishment of a Primary Epididymal Cell Model From Epididymal Samples to Study CFTR Gene Regulation
University Hospital, Brest · NCT06045702
This project will try to grow cells from epididymal tissue taken during planned surgery to see if they reveal how the CFTR gene is regulated in adult men with infertility, cystic fibrosis, or absence of the vas deferens.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University Hospital, Brest (other) |
| Locations | 1 site (Brest) |
| Trial ID | NCT06045702 on ClinicalTrials.gov |
What this trial studies
This observational project collects epididymal tissue samples during scheduled urologic surgery and establishes primary epididymal cell cultures. Researchers will map the 3D organization of chromatin at the CFTR locus and identify regulatory elements active in these cells. Participants include adult men undergoing epididymal sampling, including those with male infertility, cystic fibrosis, or congenital bilateral absence of the vas deferens. The goal is to connect CFTR regulatory architecture in epididymal cells to mechanisms underlying certain forms of male infertility.
Who should consider this trial
Good fit: Adult men (18+) who are scheduled for epididymal sampling surgery and can provide informed consent, including those with cystic fibrosis or bilateral absence of the vas deferens, are ideal candidates.
Not a fit: People who are not having epididymal harvesting surgery, minors, those under legal protection, or anyone seeking immediate clinical treatment rather than contributing tissue for research are unlikely to benefit directly.
Why it matters
Potential benefit: If successful, this work could improve understanding of how CFTR-related regulation contributes to male infertility and guide future diagnostic or therapeutic research.
How similar studies have performed: Related 3D chromatin and CFTR regulation studies have been done in other tissues, but using primary epididymal cells for this question is relatively novel and less well studied.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brest
- Antoine VALERI — Brest, France (RECRUITING)
Study contacts
- Principal investigator: Antoine VALERI, MD,PhD — University Hospital, Brest
- Study coordinator: Antoine VALERI, MD,PhD
- Email: Antoine.Valeri@univ-brest.fr
- Phone: +33298347170
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cystic Fibrosis, Congenital Bilateral Absence of Vas Deferens, Sterility, Male, Infertility, Primary epididymal cells