Epigenetic Integrity of Spermatozoa in Patients With Germinal Testicular Tumours

Brief Title

Epigenetic Integrity of Spermatozoa in Patients With Germinal Testicular Tumours

Official Title

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

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.
    



Study Type

Observational


Primary Outcome

Analysis of methylation profiles in paternal genes subjected to imprinting (GSI)


Condition

Seminomas

Intervention

Extraction genomic DNA

Study Arms / Comparison Groups

 testicular tumours
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

90

Start Date

September 2016

Completion Date

September 2017

Primary Completion Date

September 2017

Eligibility Criteria

        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
      

Gender

Male

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT03262207

Organization ID

DESCH AOI 2016


Responsible Party

Sponsor

Study Sponsor

Centre Hospitalier Universitaire Dijon


Study Sponsor

, , 


Verification Date

August 2017