Testicular Germ Cell CancerTG-BILNCT07463508
Evaluation of Bile Acid Concentrations and Their Signaling as Markers of Testicular Tumorigenesis and Germ Cell Tumor Chemosensitivity
A study testing blood sampling and Tissue sampling in people with Testicular Germ Cell Cancer, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
This is a study exploring measurable markers in the blood of patients with testicular tumors. The investigators will focus on the importance of measuring and analyzing these markers for their prognostic value and predictive response to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Testicular Germ Cell Cancer
- What is being tested?
- blood sampling and Tissue sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2026to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient, male, with a clinical and biological diagnosis of germ cell tumor of the testis in pre-orchidectomy, at the stage of the disease and any histological subtype of germ cell tumor
- Affiliation with a Social Security organization
- Able to give informed consent to participate in the research.
Who cannot join
- Patient with a hepatobiliary pathology
- Patient treated with Colestyramine
- Patient who has undergone cholecystectomy or extensive resection of the small intestine
- Patient deprived of liberty
- Patient under guardianship, curatorship, or legal protection
- Patient unable to understand the protocol (language barrier, cognitive difficulties)
Show all 9Show fewer
- Patient with another active cancer
- Patient participating in a therapeutic clinical trial
- Refusal to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand
Lise Laclautre, promo_interne_drci@chu-clermontferrand.fr
Aurore DOUGE
About this study
Official title: Evaluation of Bile Acid Concentrations and Their Signaling as Markers of Testicular Tumorigenesis and Germ Cell Tumor Chemosensitivity (TG-BIL)
This is a study exploring measurable markers in the blood of patients with testicular tumors. The investigators will focus on the importance of measuring and analyzing these markers for their prognostic value and predictive response to treatment.
- Conditions
- Testicular Germ Cell Cancer
- Being tested
- blood sampling, Tissue sampling
- Keywords
- biomarker, acid biliary, testicular germ cell cancer
- Medical subject headings
- Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingBiological
Blood samples will allow the measurement of AFP, LDH and HCG as well as the measurement of testosterone, glucose, cholesterol, triglycerides and bile acids
Tissue samplingProcedure or surgery
On these tissues (tumoral and non-tumoral), the investigators will carry out analysis of the bile acid composition by mass spectrometry, molecular characterization by RNAseq, histological characterization and analysis in cell culture
| Study group | Role | What they receive |
|---|---|---|
| Patient with a testicular cell germ tumor | Other | All patients will have the same samples, at the time of orchidectomy, then during chemotherapy and during follow-up. Receives: Biological: blood sampling; Procedure: Tissue sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare bile acid levels in healthy testicular tissues and in tumorous testicular tissues in patients with testicular germ cell tumor
The investigators hypothesis is that bile acid levels are higher in tumor tissues compared to those present in healthy tissues of patients with testicular germ cell tumors, making them a marker of these tumors. Furthermore, the investigators suggest that blood bile acid levels and their composition are a relevant prognostic marker of these tumors.
Measured: During orchidectomy
Secondary outcomes (7)
Composition of bile acids in healthy and tumor testicular tissues
Measured: Perioperative
Correlation between blood bile acid levels and survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Correlation between blood bile acid levels and the prognostic stage
Measured: From enrollment to 24 months after the end of treatment
Correlation between bile acid levels and tumor markers
Measured: From enrollment to 24 months after the end of treatment
Correlation bile acid levels kinetics with the response to chemotherapy
Measured: From enrollment to 24 months after the end of treatment
Correlation between bile acid level kinetics and survival
Measured: From enrollment to 24 months after the end of treatment
Analysis of chemosensitivity of tumor cells in vitro
Measured: From the end of chemotherapy to 24 months after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start1 Jan 2026
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testicular Germ Cell CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective single-center study, RIPH type 2 protocol
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463508
- Sponsor's protocol ID
- RBHP 2025 DOUGE
- Acronym
- TG-BIL
- Status last verified
- Dec 2025
- First submitted
- 26 Dec 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bile Acid Concentrations and Their Signaling as Markers of Testicular Tumorigenesis and Germ Cell Tumor Chemosensitivity (TG-BIL)
- ClinicalTrials.gov ID
- NCT07463508
- Acronym / sponsor ID
- TG-BIL / RBHP 2025 DOUGE
- Conditions
- Testicular Germ Cell Cancer
- Keywords
- biomarker, acid biliary, testicular germ cell cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 11 Mar 2026 (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.
This is a study exploring measurable markers in the blood of patients with testicular tumors. The investigators will focus on the importance of measuring and analyzing these markers for their prognostic value and predictive response to treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective single-center study, RIPH type 2 protocol
| Arm | Type | Receives |
|---|---|---|
| Patient with a testicular cell germ tumor | Other | Biological: blood sampling, Procedure: Tissue samplingAll patients will have the same samples, at the time of orchidectomy, then during chemotherapy and during follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patient, male, with a clinical and biological diagnosis of germ cell tumor of the testis in pre-orchidectomy, at the stage of the disease and any histological subtype of germ cell tumor
- Affiliation with a Social Security organization
- Able to give informed consent to participate in the research.
Key exclusion criteria (9 listed)
- Patient with a hepatobiliary pathology
- Patient treated with Colestyramine
- Patient who has undergone cholecystectomy or extensive resection of the small intestine
- Patient deprived of liberty
- Patient under guardianship, curatorship, or legal protection
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 |
|---|---|---|
| blood samplingBlood samples will allow the measurement of AFP, LDH and HCG as well as the measurement of testosterone, glucose, cholesterol, triglycerides and bile acids | Biological | Patient with a testicular cell germ tumor |
| Tissue samplingOn these tissues (tumoral and non-tumoral), the investigators will carry out analysis of the bile acid composition by mass spectrometry, molecular characterization by RNAseq, histological characterization and analysis in cell culture | Procedure or surgery | Patient with a testicular cell germ tumor |
Primary outcome
To compare bile acid levels in healthy testicular tissues and in tumorous testicular tissues in patients with testicular germ cell tumor
Time frame: During orchidectomy
The investigators hypothesis is that bile acid levels are higher in tumor tissues compared to those present in healthy tissues of patients with testicular germ cell tumors, making them a marker of these tumors. Furthermore, the investigators suggest that blood bile acid levels and their composition are a relevant prognostic marker of these tumors.
7 secondary outcomes
Composition of bile acids in healthy and tumor testicular tissues
Time frame: Perioperative
Correlation between blood bile acid levels and survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Correlation between blood bile acid levels and the prognostic stage
Time frame: From enrollment to 24 months after the end of treatment
Correlation between bile acid levels and tumor markers
Time frame: From enrollment to 24 months after the end of treatment
Correlation bile acid levels kinetics with the response to chemotherapy
Time frame: From enrollment to 24 months after the end of treatment
Correlation between bile acid level kinetics and survival
Time frame: From enrollment to 24 months after the end of treatment
Analysis of chemosensitivity of tumor cells in vitro
Time frame: From the end of chemotherapy to 24 months after the end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sampling and Tissue sampling in people with Testicular Germ Cell Cancer, run by University Hospital, Clermont-Ferrand 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 3 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 11 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (0473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare bile acid levels in healthy testicular tissues and in tumorous testicular tissues in patients with testicular germ cell tumor (time frame: During orchidectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2026.