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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00820287
Other study ID # APN 2004
Secondary ID
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


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
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