SeminomasGAMETHNCT03262207
Epigenetic Integrity of Spermatozoa in Patients With Germinal Testicular Tumours
An observational study of Seminomas, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Seminomas
- What is being tested?
- Extraction genomic DNA, Analysis of methylation profiles of numerous GSI and TE and Analysis of methylation for the whole genome (sub-population of 15 samples from group 1)
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2016to Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: seminomas
Who may be able to join
- 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
Who cannot join
- biological samples of persons without national health insurance cover
- biological samples from patients with chronic hepatitis B or C or HIV infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Seminomas
- Being tested
- Extraction genomic DNA, Analysis of methylation profiles of numerous GSI and TE, Analysis of methylation for the whole genome (sub-population of 15 samples from group 1), Method of protein detection by immunostaining and flow cytometry
- Medical subject headings
- Seminoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extraction genomic DNAOther
Analysis of methylation profiles of numerous GSI and TEOther
Analysis of methylation for the whole genome (sub-population of 15 samples from group 1)Other
Method of protein detection by immunostaining and flow cytometryOther
| Study group | Role | What they receive |
|---|---|---|
| testicular tumours | Not described Receives: 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 | Not described Receives: 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 | Not described Receives: 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 being measured
The primary outcome is the main question the study is designed to answer.
Analysis of methylation profiles in paternal genes subjected to imprinting (GSI)
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study startSep 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SeminomasStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262207
- Sponsor's protocol ID
- DESCH AOI 2016
- Acronym
- GAMETH
- Status last verified
- Aug 2017
- First submitted
- 23 Aug 2017
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bruno C, Blagoskonov O, Barberet J, Guilleman M, Daniel S, Tournier B, Binquet C, Choux C, Fauque P. Sperm imprinting integrity in seminoma patients? Clin Epigenetics. 2018 Oct 19;10(1):125. doi: 10.1186/s13148-018-0559-z.
PubMed 30340650
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epigenetic Integrity of Spermatozoa in Patients With Germinal Testicular Tumours: Potential Risks and Consequences for the Conceptus
- ClinicalTrials.gov ID
- NCT03262207
- Acronym / sponsor ID
- GAMETH / DESCH AOI 2016
- Conditions
- Seminomas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 25 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- seminomas
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- biological samples of persons without national health insurance cover
- biological samples from patients with chronic hepatitis B or C or HIV infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extraction genomic DNA | Other | fertile, infertile, testicular tumours |
| Analysis of methylation profiles of numerous GSI and TE | Other | fertile, infertile, testicular tumours |
| Analysis of methylation for the whole genome (sub-population of 15 samples from group 1) | Other | testicular tumours |
| Method of protein detection by immunostaining and flow cytometry | Other | fertile, infertile, testicular tumours |
Primary outcome
Analysis of methylation profiles in paternal genes subjected to imprinting (GSI)
Time frame: at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Results publication: PubMed 30340650Bruno C, Blagoskonov O, Barberet J, Guilleman M, Daniel S, Tournier B, Binquet C, Choux C, Fauque P. Sperm imprinting integrity in seminoma patients? Clin Epigenetics. 2018 Oct 19;10(1):125. doi: 10.1186/s13148-018-0559-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Seminomas, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of methylation profiles in paternal genes subjected to imprinting (GSI) (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03262207, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.