Identification of Predictive Markers for Testis Cancer in a Population of Men With High Risk
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Identification of Predictive Markers for Testis Cancer in a Population of Men With High Risk|
- Analysis of 4 recognized tumorogenesis biomarkers in testicular biopsies of a population of hypofertiles men in theory supposed to present an increased incidence of testicular cancer development [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- Identification of spermatogenic achieving by conventional histology (analysis of Jonhsen's score) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- Establishment of one or more correlation (s) between the level of expression of biomarkers of tumorogenesis: Jonhsen score, the rate of circulating spermatogenesis serum markers (AMH, inhibin ...). [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- Establishment of a correlation between the level of expression of of tumorogenesis testicular biomarkers, the presence of testicular microlithiasis and carcinoma in situ of the testis [ Time Frame: 4 years ] [ Designated as safety issue: No ]
|Study Start Date:||September 2005|
|Study Completion Date:||June 2011|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Procedure: Biopsy of testicular tumor
Please refer to this study by its ClinicalTrials.gov identifier: NCT00820287
|CHU de Nice|
|Nice, France, 06000|