Identification of Predictive Markers for Testis Cancer in a Population of Men With High Risk
Primary Purpose
Testicular Cancer
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biopsy of testicular tumor
Sponsored by
About this trial
This is an interventional diagnostic trial for Testicular Cancer focused on measuring Testicular cancer, incidence, young men
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
Sites / Locations
- CHU de Nice
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Identification of spermatogenic achieving by conventional histology (analysis of Jonhsen's score)
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 ...).
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
Full Information
NCT ID
NCT00820287
First Posted
January 9, 2009
Last Updated
March 23, 2012
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT00820287
Brief Title
Identification of Predictive Markers for Testis Cancer in a Population of Men With High Risk
Official Title
Identification of Predictive Markers for Testis Cancer in a Population of Men With High Risk
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Terminated
Study Start Date
September 2005 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Testicular Cancer
Keywords
Testicular cancer, incidence, young men
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Biopsy of testicular tumor
Intervention Description
testicular biopsies performed through open surgery
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Identification of spermatogenic achieving by conventional histology (analysis of Jonhsen's score)
Time Frame
4 years
Title
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
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06000
Country
France
12. IPD Sharing Statement
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Identification of Predictive Markers for Testis Cancer in a Population of Men With High Risk
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