Evaluation of Bile Acid Concentrations and Their Signaling as Markers of Testicular Tumorigenesis and Germ Cell Tumor Chemosensitivity (TG-BIL)

March 5, 2026 updated by: University Hospital, Clermont-Ferrand

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patient with a testicular cell germ tumor
All patients will have the same samples, at the time of orchidectomy, then during chemotherapy and during follow-up.
Biological: blood sampling
Blood samples will allow the measurement of AFP, LDH and HCG as well as the measurement of testosterone, glucose, cholesterol, triglycerides and bile acids
Procedure: Tissue sampling
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During orchidectomy

Secondary Outcome Measures

Outcome Measure
Time Frame
Composition of bile acids in healthy and tumor testicular tissues
Time Frame: Perioperative
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
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
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
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
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
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
From the end of chemotherapy to 24 months after the end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

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 (Actual)

January 1, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

December 26, 2025

First Submitted That Met QC Criteria

March 5, 2026

First Posted (Actual)

March 11, 2026

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBHP 2025 DOUGE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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