Building primary epididymal cell models to look at CFTR gene regulation
Official title: Establishment of a Primary Epididymal Cell Model From Epididymal Samples to Study CFTR Gene Regulation
Run by University Hospital, Brest · NCT06045702 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 20 (estimated) |
| Sponsor | University Hospital, Brest Academic / other |
| Locations | 1 site (Brest) |
| Status | Recruiting |
| Started | September 11, 2024 |
| Main results expected | September 9, 2026 |
| Study ends | September 11, 2026 |
| Registry record updated | March 20, 2026 |
| Trial ID | NCT06045702 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Inhaled CFTR mRNA for cystic fibrosis in Chinese patients aged 12 and older
This trial tests inhaled BMD003, a CFTR mRNA therapy, to see if it's safe and shows early signs of benefit in Chinese people 12 years and up with cystic fibrosis.
-
VX-272 dose escalation in healthy adults
This will test single and multiple increasing doses of the experimental drug VX-272 in healthy adults to see how safe it is and how the body handles it.
-
Prevalence of smoking, passive smoke exposure, and vaping among adults with cystic fibrosis
This project will see how common smoking, exposure to secondhand smoke, and vaping are among adults with cystic fibrosis followed at the Strasbourg Adult CF Center.
-
Dose escalation of VX-581 to check safety and drug levels in healthy adults
The trial will test increasing doses of VX-581 in healthy adults to see if it is safe and to measure how the body absorbs and clears the drug.
-
PALMIRE cohort: phenotyping inflammatory lung diseases to enable personalized care
This project will collect clinical, imaging, and biological data from adults with asthma, COPD, bronchiectasis, cystic fibrosis, primary ciliary dyskinesia, or interstitial lung disease to try to identify disease subtypes and markers that could guide more personalized care.
-
Collecting sputum samples at home for cystic fibrosis patients
This study is testing if collecting sputum samples at home can help people with cystic fibrosis better identify lung infections compared to traditional methods done at the clinic.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.