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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00820287
First received: January 9, 2009
Last updated: March 23, 2012
Last verified: January 2009
  Purpose

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 Intervention
Testicular Cancer
Procedure: Biopsy of testicular tumor

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Identification of Predictive Markers for Testis Cancer in a Population of Men With High Risk

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

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 [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Identification of spermatogenic achieving by conventional histology (analysis of Jonhsen's score) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: September 2005
Study Completion Date: June 2011
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Biopsy of testicular tumor
    testicular biopsies performed through open surgery
  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00820287

Locations
France
CHU de Nice
Nice, France, 06000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT00820287     History of Changes
Other Study ID Numbers: APN 2004
Study First Received: January 9, 2009
Last Updated: March 23, 2012
Health Authority: France: Direction Générale de la Santé
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire de Nice:
Testicular cancer
incidence
young men

Additional relevant MeSH terms:
Testicular Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on April 21, 2014