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

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ClinicalTrials.gov Identifier: NCT00820287
Recruitment Status : Terminated
First Posted : January 12, 2009
Last Update Posted : March 26, 2012
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Tracking Information
First Submitted Date  ICMJE January 9, 2009
First Posted Date  ICMJE January 12, 2009
Last Update Posted Date March 26, 2012
Study Start Date  ICMJE September 2005
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2009)
  • Identification of spermatogenic achieving by conventional histology (analysis of Jonhsen's score) [ Time Frame: 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 ...). [ Time Frame: 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 testis [ Time Frame: 4 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Identification of Predictive Markers for Testis Cancer in a Population of Men With High Risk
Official Title  ICMJE Identification of Predictive Markers for Testis Cancer in a Population of Men With High Risk
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Testicular Cancer
Intervention  ICMJE Procedure: Biopsy of testicular tumor
testicular biopsies performed through open surgery
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 23, 2012)
44
Original Estimated Enrollment  ICMJE
 (submitted: January 9, 2009)
225
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00820287
Other Study ID Numbers  ICMJE APN 2004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire de Nice
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Nice
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Centre Hospitalier Universitaire de Nice
Verification Date January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP