Clinical Trials Directory

Trials / Terminated

TerminatedNCT00820287

Identification of Predictive Markers for Testis Cancer in a Population of Men With High Risk

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
44 (actual)
Sponsor
Centre Hospitalier Universitaire de Nice · Academic / Other
Sex
Male
Age
18 Years – 35 Years
Healthy volunteers
Not accepted

Summary

Testis cancer with germ cells is the most frequent cancer of young men and its incidence is in constant increase in many industrialized countries, as in France. An increased risk of developing testis cancer has been described in patients with testicular ectopia history and testicular cancer history (controlateral testicular cancer) and more recently suggested in a population of hypofertile men with altered spermatogenesis. To a better understanding of this risk, an attempt of characterization of this group of patients has been proposed in the present work. The general objective of this project is to characterize morphological and molecular markers of hypofertility which could serve as predictive markers of testis malignant transformation. In this project conducted in 3 establishments, the investigators propose: * To select a population of hypofertile patients exhibiting compatible clinical and morphological characters with a high risk of testis tumoral transformation (secretory azoospermia and/or a history of testicular ectopia. To determine the spermatogenic arrests on histological criteria (score of Jonhsen). * To study the expression of four proteins or family of proteins suspected of being involved in testis tumorogenesis such as: the Placenta Alkaline Phosphatase (PLAPE), cyclin A1, VASA and connexin (Cx) by immunohistochemistry and by real-time quantitative RT-PCR analysis real-time analyses. * To establish a possible correlation between the clinical data, spermatogenesis arrest and the expression of these biomarkers. These approaches would allow to identify, in this population of hypofertile patients, subgroups of men who could develop tumours with germ cells, and subsequently to propose potential biomarkers for testis cancer. A more clinical observation of these subgroups will be also proposed.

Conditions

Interventions

TypeNameDescription
PROCEDUREBiopsy of testicular tumortesticular biopsies performed through open surgery

Timeline

Start date
2005-09-01
Primary completion
2009-01-01
Completion
2011-06-01
First posted
2009-01-12
Last updated
2012-03-26

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT00820287. Inclusion in this directory is not an endorsement.