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Recruiting NCT07463508

Evaluation of Bile Acid Concentrations and Their Signaling as Markers of Testicular Tumorigenesis and Germ Cell Tumor Chemosensitivity

No phase Interventional Testicular Germ Cell Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: blood sampling, Tissue sampling.
Who it may be relevant to
Registry conditions: Testicular Germ Cell Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • 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]
Secondary outcome measures (7)
  • 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]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • CHU Clermont-Ferrand — Clermont-Ferrand

Identifiers

NCT: NCT07463508 · RBHP 2025 DOUGE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗