Epigenetic Integrity of Spermatozoa in Patients With Germinal Testicular Tumours

NCT ID: NCT03262207

Last Updated: 2017-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Seminomas

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

testicular tumours

Extraction genomic DNA

Intervention Type OTHER

Analysis of methylation profiles of numerous GSI and TE

Intervention Type OTHER

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

Intervention Type OTHER

Method of protein detection by immunostaining and flow cytometry

Intervention Type OTHER

fertile

Extraction genomic DNA

Intervention Type OTHER

Analysis of methylation profiles of numerous GSI and TE

Intervention Type OTHER

Method of protein detection by immunostaining and flow cytometry

Intervention Type OTHER

infertile

Extraction genomic DNA

Intervention Type OTHER

Analysis of methylation profiles of numerous GSI and TE

Intervention Type OTHER

Method of protein detection by immunostaining and flow cytometry

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Extraction genomic DNA

Intervention Type OTHER

Analysis of methylation profiles of numerous GSI and TE

Intervention Type OTHER

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

Intervention Type OTHER

Method of protein detection by immunostaining and flow cytometry

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Dijon Bourgogne

Dijon, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DESCH AOI 2016

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Testicular Torsion
NCT05558072 COMPLETED NA
mtDNA and Embryo Metabolism
NCT03206697 UNKNOWN