Measuring bile acids in blood and tumor tissue to help detect and predict treatment response in testicular germ cell tumors
Evaluation of Bile Acid Concentrations and Their Signaling as Markers of Testicular Tumorigenesis and Germ Cell Tumor Chemosensitivity (TG-BIL)
This project will measure bile acids and related signals in blood and tumor tissue to see if they can help detect disease and predict chemotherapy response in adult men with testicular germ cell tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 1 site (Clermont-Ferrand) |
| Trial ID | NCT07463508 on ClinicalTrials.gov |
What this trial studies
Adult men with a clinical and biological diagnosis of testicular germ cell tumor will provide blood samples and tumor tissue (typically collected before orchiectomy). Investigators will quantify bile acid concentrations and related signaling markers in blood and tissue and link those measurements to tumor histology, disease stage, and chemotherapy response. The study excludes patients with conditions or surgeries that change bile acid metabolism to avoid confounding results. Clinical follow-up data will be used to test whether these markers correlate with prognosis or chemosensitivity.
Who should consider this trial
Good fit: Adult men with a confirmed testicular germ cell tumor before orchiectomy who can give informed consent and are affiliated with the French social security system are eligible.
Not a fit: Patients with hepatobiliary disease, those treated with cholestyramine, people who have had cholecystectomy or major small-bowel resection, patients with another active cancer, or those already enrolled in a therapeutic clinical trial are excluded and unlikely to benefit from this biomarker work.
Why it matters
Potential benefit: If successful, the biomarkers could help identify more aggressive disease earlier and predict which patients are likely to respond to chemotherapy, supporting more personalized treatment decisions.
How similar studies have performed: Using bile acid signaling as a biomarker in testicular cancer is largely exploratory; bile acids have been studied in other cancers and metabolic disorders but evidence for predicting germ cell tumor chemosensitivity is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Clermont-Ferrand
- CHU Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
Study contacts
- Study coordinator: Lise LACLAUTRE
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: 0473754963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.