Actively Recruiting
Evaluation of Bile Acid Concentrations and Their Signaling as Markers of Testicular Tumorigenesis and Germ Cell Tumor Chemosensitivity
Led by University Hospital, Clermont-Ferrand · Updated on 2026-03-11
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring measurable markers in the blood of adult male patients diagnosed with testicular germ cell tumors. The study focuses on understanding bile acid concentrations and their signaling in both healthy and tumorous testicular tissues to assess their potential value in predicting tumor behavior and response to chemotherapy. All participants will provide blood and tissue samples at specific times: during orchidectomy (surgical removal of the testis), throughout chemotherapy, and during follow-up visits. Blood samples will be analyzed for various substances including AFP, LDH, HCG, testosterone, glucose, cholesterol, triglycerides, and bile acids. Tissue samples from both tumor and non-tumor areas will undergo detailed analysis using techniques such as mass spectrometry and RNA sequencing. Participants will be monitored over time with assessments to compare bile acid levels between healthy and tumor tissues, evaluate correlations between blood bile acid levels and survival, prognostic stages, tumor markers, and chemotherapy response. Chemosensitivity of tumor cells will also be studied in vitro up to 24 months after treatment ends. The study will last through follow-up periods extending up to 100 months, with careful collection of clinical data and biological samples to measure outcomes and safety.
CONDITIONS
Brief Title
Evaluation of Bile Acid Concentrations and Their Signaling as Markers of Testicular Tumorigenesis and Germ Cell Tumor Chemosensitivity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult male patient with a clinical and biological diagnosis of germ cell tumor of the testis before orchidectomy
- Any stage of the disease and any histological subtype of germ cell tumor
- Affiliated with a Social Security organization
- Able to provide informed consent to participate in the research
You will not qualify if you...
- Presence of hepatobiliary pathology
- Treatment with Colestyramine
- Previous cholecystectomy or extensive resection of the small intestine
- Patient deprived of liberty
- Under guardianship, curatorship, or legal protection
- Unable to understand the protocol due to language barrier or cognitive difficulties
- Presence of another active cancer
- Currently participating in a therapeutic clinical trial
- Refusal to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At time of orchidectomy
Participants undergo tissue and blood sampling during orchidectomy to analyze bile acid composition and tumor markers.
1 perioperative visit (in-person)
Duration - Duration of chemotherapy
Participants receive chemotherapy with ongoing blood sampling to evaluate bile acid levels and tumor marker correlations.
Multiple visits during chemotherapy
Duration - Up to 24 months after the end of treatment
Participants are monitored with blood sampling and assessments to correlate bile acid levels with survival and chemotherapy response for up to 24 months after treatment ends.
Regular follow-up visits over 24 months
Trial Site Locations
Total: 1 location
1
CHU Clermont-Ferrand
Clermont-Ferrand, France
Actively Recruiting
Research Team
L
Lise LACLAUTRE
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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