Evaluation of Bile Acid Concentrations and Their Signaling as Markers of Testicular Tumorigenesis and Germ Cell Tumor Chemosensitivity (TG-BIL)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To compare bile acid levels in healthy testicular tissues and in tumorous testicular tissues in patients with testicular germ cell tumor
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Masking Description
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: blood sampling (Biological)
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.
干预措施: Tissue sampling (Procedure)
结局指标
主要结局
To compare bile acid levels in healthy testicular tissues and in tumorous testicular tissues in patients with testicular germ cell tumor
时间窗: 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.
次要结局
- 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)
- Correlation between bile acid level kinetics and survival(From enrollment to 24 months after the end of treatment)
- Analysis of chemosensitivity of tumor cells in vitro(From the end of chemotherapy to 24 months after the end of treatment)