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

NCT07463508 | Recruiting

• 1 other identifier: RBHP 2025 DOUGE
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Testicular Germ Cell Cancer

Keywords

biomarker; acid biliary; testicular germ cell cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  During orchidectomy

Secondary Outcomes (7)

• Composition of bile acids in healthy and tumor testicular tissues

  Perioperative

• Correlation between blood bile acid levels and survival

  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

  From enrollment to 24 months after the end of treatment

• Correlation between bile acid levels and tumor markers

  From enrollment to 24 months after the end of treatment

• Correlation bile acid levels kinetics with the response to chemotherapy

  From enrollment to 24 months after the end of treatment

Study Arms (1)

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.

Biological: blood sampling; Procedure: Tissue sampling

Interventions

blood sampling BIOLOGICAL

Blood samples will allow the measurement of AFP, LDH and HCG as well as the measurement of testosterone, glucose, cholesterol, triglycerides and bile acids

Patient with a testicular cell germ tumor

Tissue sampling PROCEDURE

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

Patient with a testicular cell germ tumor

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

RECRUITING

MeSH Terms

Conditions

Testicular Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Lise LACLAUTRE

CONTACT

0473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Masking Description
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective single-center study, RIPH type 2 protocol

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: March 11, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: March 11, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)