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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00820287
Enrollment
44
Registered
2009-01-12
Start date
2005-09-30
Completion date
2011-06-30
Last updated
2012-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Testicular Cancer

Keywords

Testicular cancer, incidence, young men

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.

Interventions

PROCEDUREBiopsy of testicular tumor

testicular biopsies performed through open surgery

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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 development4 years

Secondary

MeasureTime frame
Identification of spermatogenic achieving by conventional histology (analysis of Jonhsen's score)4 years
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
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 testis4 years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026