CHU Clermont-Ferrand
Clermont-Ferrand, France
Location status: Recruiting
Recruiting
NCT Number: NCT07463508
Evaluation of Bile Acid Concentrations and Their Signaling as Markers of Testicular Tumorigenesis and Germ Cell Tumor Chemosensitivity
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
Male
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- 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)
- Patient with another active cancer
- Patient participating in a therapeutic clinical trial
- Refusal to participate
Treatment and study plan
Blood sampling
BiologicalBlood samples will allow the measurement of AFP, LDH and HCG as well as the measurement of testosterone, glucose, cholesterol, triglycerides and bile acids
Tissue sampling
ProcedureOn 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
Primary outcomes
-
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.
Secondary outcomes
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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
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University Hospital, Clermont-Ferrand
Other
Registry information
Official study title
Evaluation of Bile Acid Concentrations and Their Signaling as Markers of Testicular Tumorigenesis and Germ Cell Tumor Chemosensitivity (TG-BIL)
Acronym: TG-BIL
Important dates
- Study start
- 2026
- Primary completion
- 2029
- Study completion
- 2029
- First posted
- Mar 11, 2026
- Registry last updated
- Mar 11, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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