CClinicalTrials.gg
Status unknownNCT03262207GAMETHUpdated Aug 25, 2017

Epigenetic Integrity of Spermatozoa in Patients With Germinal Testicular Tumours

An observational study in Seminomas, sponsored by Centre Hospitalier Universitaire Dijon. Status unknown at 1 site in France. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-25.

Sponsored by Centre Hospitalier Universitaire Dijon · Observational

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
90
Ages
18 Years and older
Sex
Male
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Study 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.

02

Conditions studied

  • Seminomas
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

seminomas

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

Exclusion Criteria:

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

Observational model
Other
Time perspective
Other
Enrollment
90 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • OtherExtraction genomic DNA
  • OtherAnalysis of methylation profiles of numerous GSI and TE
  • OtherAnalysis of methylation for the whole genome (sub-population of 15 samples from group 1)
  • OtherMethod of protein detection by immunostaining and flow cytometry
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What researchers measure

Primary outcomes

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

    Time frame: at baseline

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Study locations

1 site
  • CHU Dijon Bourgogne
    Dijon, 21079, France
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Registry details

Key details

Study ID
NCT03262207
Lead sponsor
Centre Hospitalier Universitaire Dijon
Responsible party
Sponsor
First posted
Aug 25, 2017
Start date
Sep 2016
Primary completion
Sep 2017 (estimated)
Completion
Sep 2017 (estimated)
Last update
Aug 25, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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