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

University Hospital, Clermont-Ferrand20 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Testicular Germ Cell Cancer

Interventions

blood samplingBIOLOGICAL

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

Tissue samplingPROCEDURE

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

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: During orchidectomy

Secondary Outcomes

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

Central Contacts

Lise LACLAUTRE

CONTACT

0473754963 promo_interne_drci@chu-clermontferrand.fr

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.