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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00820287
Recruitment Status : Terminated
First Posted : January 12, 2009
Last Update Posted : March 26, 2012
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

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.

Condition or disease Intervention/treatment Phase
Testicular Cancer Procedure: Biopsy of testicular tumor Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Identification of Predictive Markers for Testis Cancer in a Population of Men With High Risk
Study Start Date : September 2005
Actual Primary Completion Date : January 2009
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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 Measures :
  1. Identification of spermatogenic achieving by conventional histology (analysis of Jonhsen's score) [ Time Frame: 4 years ]
  2. 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 ]
  3. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00820287

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CHU de Nice
Nice, France, 06000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
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Responsible Party: Centre Hospitalier Universitaire de Nice Identifier: NCT00820287    
Other Study ID Numbers: APN 2004
First Posted: January 12, 2009    Key Record Dates
Last Update Posted: March 26, 2012
Last Verified: January 2009
Keywords provided by Centre Hospitalier Universitaire de Nice:
Testicular cancer
young men
Additional relevant MeSH terms:
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Testicular Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders