Epigenetic Integrity of Spermatozoa in Patients With Germinal Testicular Tumours

• Conditions: Seminomas
• Interventions: Other: Extraction genomic DNA; Other: Analysis of methylation profiles of numerous GSI and TE; Other: Method of protein detection by immunostaining and flow cytometry; Other: Analysis of methylation for the whole genome (sub-population of 15 samples from group 1)

• Registration Number: NCT03262207
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

Recent data suggest that sperm cells carry an epigenetic message during spermatogenesis and that this message is crucial for the future development of the embryo. This epigenetic signature is notably represented by methylation of genes subjected to imprinting (GSI) and the methylation of transposable elements (TE). Data on the maintenance of the imprint and of the control of TE accompanying human gametogenesis in a context of adult germinal testicular cancers, seminomas, are extremely fragmentary for tumour tissues and inexistent for gametes.

The aim of this study is to determine whether patients with seminomas in comparison with fertile men carry a higher risk of presenting epigenetic alterations affecting their gametes.

This study is based on the use of an existing collection of biological samples. 90 samples will be selected and split into 3 groups:

* Group 1: 30 sperm samples from patients with seminomatous testicular tumours

* Group 2: 30 sperm samples from fertile patients

* Group 3: 30 sperm samples from infertile patients

After treatment of the samples (thawing, cell sorting and removal of cryoprotectants), they will be analysed.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Status Verified: 2017-08
• Study First Submitted: 2017-08-23
• Study First Submitted QC: 2017-08-23
• Last Update Submitted: 2017-08-23
• Study First Posted: 2017-08-25
• Last Update Posted: 2017-08-25
• Primary Completion: 2017-09
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 90

Inclusion Criteria

• biological samples from persons who have provided written consent
• biological samples of patients over 18 years old
• with testicular tumours/Fertile/Infertile
• Matched for age with patients suffering from testicular tumours

Exclusion Criteria

• biological samples of persons without national health insurance cover
• biological samples from patients with chronic hepatitis B or C or HIV infection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
testicular tumours	Extraction genomic DNA	-
fertile	Extraction genomic DNA	-
infertile	Method of protein detection by immunostaining and flow cytometry	-
fertile	Method of protein detection by immunostaining and flow cytometry	-
infertile	Analysis of methylation profiles of numerous GSI and TE	-
testicular tumours	Method of protein detection by immunostaining and flow cytometry	-
testicular tumours	Analysis of methylation profiles of numerous GSI and TE	-
testicular tumours	Analysis of methylation for the whole genome (sub-population of 15 samples from group 1)	-
fertile	Analysis of methylation profiles of numerous GSI and TE	-
infertile	Extraction genomic DNA	-

Primary Outcome Measures

Name	Time	Method
Analysis of methylation profiles in paternal genes subjected to imprinting (GSI)	at baseline

Trial Locations

Locations (1)

CHU Dijon Bourgogne; 🇫🇷 Dijon, France