跳至主要内容
临床试验/NCT03262207
NCT03262207Unknown不适用

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

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
90
试验地点
1
主要终点
Analysis of methylation profiles in paternal genes subjected to imprinting (GSI)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

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

时间窗: at baseline

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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