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

ConditionTesticular Germ Cell Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity Hospital, Clermont-Ferrand

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • blood sampling

    Biological/Vaccine

    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 sampling

    Procedure/Surgery

    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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Patient with a testicular cell germ tumorOther 2 interventions

Trial outcomes

Primary outcomes

1

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

1

Composition of bile acids in healthy and tumor testicular tissues

Time frame
Perioperative
2

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
3

Correlation between blood bile acid levels and the prognostic stage

Time frame
From enrollment to 24 months after the end of treatment
4

Correlation between bile acid levels and tumor markers

Time frame
From enrollment to 24 months after the end of treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Clermont-Ferrand

Lead sponsor

Source ClinicalTrials.gov
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