Epigenetic Integrity of Spermatozoa in Patients With Germinal Testicular Tumours (GAMETH)

August 23, 2017 updated by: Centre Hospitalier Universitaire Dijon

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • CHU Dijon Bourgogne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

seminomas

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Analysis of methylation profiles in paternal genes subjected to imprinting (GSI)
Time Frame: at baseline
at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

August 23, 2017

First Submitted That Met QC Criteria

August 23, 2017

First Posted (Actual)

August 25, 2017

Study Record Updates

Last Update Posted (Actual)

August 25, 2017

Last Update Submitted That Met QC Criteria

August 23, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DESCH AOI 2016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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