Clinical Trial: A Case-control Study to Assess the Association Between Environmental, Domestic and Occupational Exposures and the Risk of Testicular Germ Cell Tumor

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: A Multicentric Case-control Study to Assess the Association Between Environmental, Domestic and Occupational Exposures During Antenatal and Early Postnatal Periods and the Risk to Develop a Testicular

Brief Summary:

The incidence of testicular germ cell tumors, the most common cancer in men aged 15 to 45 years, has doubled in France in 30 years. Reasons remain unclear but a role of environmental factors, especially during critical periods of development, is strongly suspected. Reliable data on environmental exposure during this critical period are sparse.The discordant findings and the limitations of available studies underline the importance to conduct studies with sufficient statistical power to detect risk due to exposures during critical windows of vulnerability.

We conduct a multicentric case-control study to assess this association. Cases and controls will be enrolled during a 18-month period. They will be interviewed by professional telephone interviewers about their occupational and residential history and about their domestic exposure to pesticides and other nuisances.

An optional biological study to assess genetic polymorphisms known to be associated with testicular cancer will be proposed to every cases and controls.

Mothers (or close relative) of cases and controls will also be contacted (with son's agreement). If they agree to participate, they will also be interviewed about antenatal and early life exposure of their sons to pesticides and other nuisances.

Cases will be matched up with 2 controls (one of each group) both on age (+/- 2 years) and on recruiting center.


Detailed Summary:

Environmental exposure to pesticides will be assessed from subject's residential history, using a Geographic Information System.

Occupational exposure to pesticides and other nuisances will be assessed by an industrial hygienist who will be in charge to encode all subjects and mothers' occupations.

Domestic exposure to pesticides will be assessed from type, target and frequency of domestic pesticide use.

Based on these 3 sources of exposure, a score of exposition will be calculated for each case and each control.


Sponsor: Centre Leon Berard

Current Primary Outcome: Assess the association between pesticide exposure during Antenatal and Early Postnatal Periods and the risk of testicular cancer during adulthood [ Time Frame: at the end of enrollment (18 months) ]

Occupational, environmental and domestic exposures to pesticides and other nuisances will be assessed.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Assess the association between a combined exposure to pesticides and the risk of testicular cancer during adulthood [ Time Frame: at the end of enrollment (18 months) ]

    The association will be assessed during antenatal, postnatal early life and later life (adolescence and adulthood).

    Occupational, environmental and domestic exposures to pesticides and other nuisances will be assessed.

  • Analyse polymorphisms known to be associated with testicular cancer risk to explore gene-environment interactions [ Time Frame: one year after the end of enrollment ]

    Polymorphisms involved in organochlorine metabolism pathways will also be assessed.

    Biological study



Original Secondary Outcome:

  • Assess the association between a combined exposure to pesticides and the risk of testicular cancer during adulthood [ Time Frame: at the end of enrollment (18 months) ]

    The association will be assessed during antenatal, postnatal early life and later life (adolescence and adulthood).

    Occupational, environmental and domestic exposures to pesticides and other nuisances will be assessed.

  • Analyse polymorphisms known to be associated with testicular cancer risk to explore gene-environment interactions [ Time Frame: one year after the end of enrollment ]

    Polymorphims involved in organochlorine metabolism pathways will also be assessed.

    Biological study



Information By: Centre Leon Berard

Dates:
Date Received: April 8, 2014
Date Started: January 2015
Date Completion: July 2017
Last Updated: November 30, 2016
Last Verified: November 2016