Epigenetic Integrity of Spermatozoa in Patients With Germinal Testicular Tumours

Seminomas Clinical Trial

— GAMETH  

Official title:

Epigenetic Integrity of Spermatozoa in Patients With Germinal Testicular Tumours: Potential Risks and Consequences for the Conceptus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03262207
• Other study ID #: DESCH AOI 2016
• Status: Active, not recruiting
• Phase: N/A
• First received: August 23, 2017
• Last updated: August 23, 2017
• Start date: September 2016
• Est. completion date: September 2017

Study information

• Verified date: August 2017
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Seminoma
• Seminomas
• Testicular Neoplasms

Intervention

Other:
• Extraction genomic DNA

• Analysis of methylation profiles of numerous GSI and TE

• Analysis of methylation for the whole genome (sub-population of 15 samples from group 1)

• Method of protein detection by immunostaining and flow cytometry

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of methylation profiles in paternal genes subjected to imprinting (GSI)		at baseline