Analysis of Transposon Control Pathways in Germinal Cancers of the Testicle (SEMINOMES)

August 16, 2016 updated by: Centre Hospitalier Universitaire Dijon
By analogy with the mouse, the activity of control pathways for transposable elements (TE) in foetal primordial germinal cells could prove to be a determinant for fertility in adulthood in humans. Moreover, defects in the control of transposable elements (TE) could also contribute to the aetiology of germinal testicular cancer, by inducing chromosomal instability and tumorigenesis. In this context, the aim is to analyse a specific type of adult germinal testicular cancers, seminomas. Directly related to our research interest, the histological, transcriptomic and epigenetic features of theses adult tumours are reminiscent of germinal cells normally present in foetuses. The investigator postulates that these similarities could also extend to the biology of transposable elements (TE), and in particular to the initiation of the control of these elements. The management of seminomas requires surgery, orchiectomy, which consists of the total excision of the affected testicles. Using high-resolution high-throughput sequencing techniques, we propose to analyse the control pathways of transposable elements (TE) in tumour samples harvested from surgical pieces in comparison with adjacent healthy tissue. The results obtained in these tumour samples will be compared with those in normal foetal gonad samples.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

15

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

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

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

men with germinal testicular cancer

Description

Inclusion Criteria:

  • men who have provided oral consent
  • men with germinal testicular cancer with negative or low serum markers (Alpha Foeto Protein AFP and Human Chorionic Gonadotrophin hCG), indicators of a seminomatous-type tumour
  • men who have undergone orchiectomy (total excision of the affected testicle)
  • confirmation of the diagnosis of seminomatous or non-seminomatous type by histology of the surgical piece
  • absence of hepatitis B or C or infection with human immunodeficiency virus (HIV).

Exclusion Criteria:

  • men without national health insurance cover
  • Adults under guardianship

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
7/8 cases pure seminomas
Genetic: Extraction of total RNA from healthy and tumour tissues
5 cases of non-seminoma
Genetic: Extraction of total RNA from healthy and tumour tissues
3 cases of composite tumours seminoma/non-seminoma.
Genetic: Extraction of total RNA from healthy and tumour tissues

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The role of Transposable Element in tumorigenesis seminomas adults
Time Frame: through the study completion up to 36 months
Transcriptomic analysis of adult seminomas
through the study completion up to 36 months

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

April 1, 2015

Primary Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

August 4, 2016

First Submitted That Met QC Criteria

August 16, 2016

First Posted (Estimate)

August 22, 2016

Study Record Updates

Last Update Posted (Estimate)

August 22, 2016

Last Update Submitted That Met QC Criteria

August 16, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • FAUQUE 2014

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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