Testicular Germ Cell Cancer
Conditions
Keywords
biomarker, acid biliary, testicular germ cell cancer
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.
Interventions
BIOLOGICALblood 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
PROCEDURETissue 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
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Masking Description
Intervention model description
Prospective single-center study, RIPH type 2 protocol
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To compare bile acid levels in healthy testicular tissues and in tumorous testicular tissues in patients with testicular germ cell tumor | 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 bile acid levels kinetics with the response to chemotherapy | 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 |
Countries
France
Contacts
CONTACTLise LACLAUTRE
Outcome results
None listed