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Establishment of a Primary Epididymal Cell Model From Epididymal Samples to Study CFTR Gene Regulation (CFTR-EP)

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ClinicalTrials.gov Identifier: NCT06045702
Recruitment Status : Not yet recruiting
First Posted : September 21, 2023
Last Update Posted : September 25, 2023
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Tracking Information
First Submitted Date September 14, 2023
First Posted Date September 21, 2023
Last Update Posted Date September 25, 2023
Estimated Study Start Date September 2023
Estimated Primary Completion Date September 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 22, 2023)		 3D organisation of chromatin at the CFTR locus [ Time Frame: 2 years ]
Cultur Cell Model
Original Primary Outcome Measures
 (submitted: September 14, 2023)		 Obtaining an epididymal cell model [ Time Frame: 1 month ]
Verification of the correct expression of the CFTR gene in this cell type will be carried out by quantification of CFTR proteins (Western blot), expression and RNA assay (RT-qPCR).
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: September 14, 2023)
  • Demonstration of interactions between genomic region [ Time Frame: 2 years ]
    Chromatin conformation analysis, using the Chromosome Conformation Capture technique (3C) and its derivatives (4C, 5C)
  • Identification of transcription factors [ Time Frame: 2 years ]
    Chromatin immunoprecipitation (Chromatin Immunoprecipitation ChIP, or Cut&Run) will be used to analyze the binding of regulatory proteins.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Establishment of a Primary Epididymal Cell Model From Epididymal Samples to Study CFTR Gene Regulation
Official Title Establishment of a Primary Epididymal Cell Model From Epididymal Samples to Study CFTR Gene Regulation
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..
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The target population for this study will be adult male patients with all types of male infertility due to genital defects, including epididymal defects due to obstruction or agenesis of the vas deferens, cystic fibrosis or male infertility due to bilateral agenesis of the vas deferens.
Condition
  • Cystic Fibrosis
  • Congenital Bilateral Absence of Vas Deferens
  • Sterility, Male
Intervention Procedure: Epididymal sample
During a planned surgical procedure carried out by the Urology and Medically Assisted Reproduction (MAP) department at Brest University Hospital in the patients included in the study, a remnant epididymal sample (between ½ and ¼ of a cc) will be kept for research purposes. These patients suffer from male infertility, leading them to undergo surgery in order to check for the presence of spermatozoa in the epididymis, and to recover spermatozoa which will be frozen and flaked in the AMP department of the CHU Brest, in the event of future procreation by in vitro fertilisation.
Study Groups/Cohorts
  • Group control
    Adult patients with no genetic pathology other than male infertility of any type leading to an inability to procreate without medical assistance, and requiring surgery to recover spermatozoa for possible in vitro fertilization.
    Intervention: Procedure: Epididymal sample
  • CFTR-associated pathology
    Major patients with cystic fibrosis or male infertility due to agenesis of the vas deferens. These patients will be included in the study because they have the prospect of procreation by in vitro fertilisation requiring surgery to recover spermatozoa.
    Intervention: Procedure: Epididymal sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: September 14, 2023)		 20
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2025
Estimated Primary Completion Date September 2025   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Antoine VALERI, MD,PhD +33298347170 Antoine.Valeri@univ-brest.fr
Contact: Stéphanie MOISAN, PhD +332 98 01 65 67 stephanie.moisan@chu-brest.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT06045702
Other Study ID Numbers 29BRC22.0273
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: All collected data that underlie results in a publication
Supporting Materials: Study Protocol
Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion.
Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
Current Responsible Party University Hospital, Brest
Original Responsible Party Same as current
Current Study Sponsor University Hospital, Brest
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Antoine VALERI, MD,PhD University Hospital, Brest
PRS Account University Hospital, Brest
Verification Date September 2023