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

Официальное название

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

Обзор

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.

Вмешательства

• Биопрепарат 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
• Процедура 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

Первичные конечные точки

• To compare bile acid levels in healthy testicular tissues and in tumorous testicular tissues in patients with testicular germ cell tumor [Срок оценки: During orchidectomy]

Вторичные конечные точки (7)

• Composition of bile acids in healthy and tumor testicular tissues [Срок оценки: Perioperative]
• Correlation between blood bile acid levels and survival [Срок оценки: 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 [Срок оценки: From enrollment to 24 months after the end of treatment]
• Correlation between bile acid levels and tumor markers [Срок оценки: From enrollment to 24 months after the end of treatment]
• Correlation bile acid levels kinetics with the response to chemotherapy [Срок оценки: From enrollment to 24 months after the end of treatment]
• Correlation between bile acid level kinetics and survival [Срок оценки: From enrollment to 24 months after the end of treatment]
• Analysis of chemosensitivity of tumor cells in vitro [Срок оценки: From the end of chemotherapy to 24 months after the end of treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Франция · 1 центр

• CHU Clermont-Ferrand — Clermont-Ferrand

Идентификаторы

NCT: NCT07463508 · RBHP 2025 DOUGE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗