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

NCT ID: NCT00820287

Last Updated: 2012-03-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2011-06-30

Brief 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

Testicular Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

Biopsy of testicular tumor

testicular biopsies performed through open surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with infertility azoospermia
• Age 18 to 35 years
• Definition of clinical and biological character of azoospermia: testicular volume less than 10 ml and FSH more than 10 IU / l
• Normal karyotype
• Surgical exploration included in a standardized medical aid to procreation
• Testicular biopsy performed by traditional surgery
• Patient informed about the research protocol and having signed consent to conduct a further testicular biopsy included in this study.

Exclusion Criteria

• adults protected by law, minors
• Individuals who are not affiliated to a social security
• Subjects hospitalized for any reason other than research.
• Patients will be used to support reproductive techniques:
• Positive serology (HIV, hepatitis ...).
• Patients with karyotype anomalies and unfavourable genetic counselling

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Nice

Nice, , France

Countries

France

Other Identifiers

APN 2004

Identifier Type: -

Identifier Source: org_study_id