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

Testicular Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00820287
• Other study ID #: APN 2004
• Status: Terminated
• Phase: N/A
• First received: January 9, 2009
• Last updated: March 23, 2012
• Start date: September 2005
• Est. completion date: June 2011

Study information

• Verified date: January 2009
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la SantéFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: June 2011
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Testicular Cancer
• Testicular Neoplasms

Intervention

Procedure:
• Biopsy of testicular tumor
testicular biopsies performed through open surgery

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		4 years	No
Secondary	Identification of spermatogenic achieving by conventional histology (analysis of Jonhsen's score)		4 years	No
Secondary	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 ...).		4 years	No
Secondary	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		4 years	No