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

Study Overview
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Brief Summary
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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 Description
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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.

Official Title
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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 Germ Cell Tumor During Adulthood

Conditions
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Testicular Germ Cell Tumor

Intervention / Treatment
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* Other: Phone interview and blood test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men aged between 18 and 44 years old Born in metropolitan France Able to understand, read and write French Without any psychiatric and severe cognitive disorder Willingness to participate to the study Who has signed and dated an inform consent form Affiliated to a health care system Exclusion Criteria: Who has a legal guardian History of testicular germ cell tumor or cryptorchidism (only for controls)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases: testicular cancer patients<br> | Other: Phone interview and blood test<br>* Subjects will be interviewed about environmental, domestic and occupational exposures during several periods of life Two blood samples will be collected at enrollment to study genetic polymorphisms<br>|
| Group A controls<br>Sperm donors and husbands of women with fertility disorders All controls must have a normal spermogram | Other: Phone interview and blood test<br>* Subjects will be interviewed about environmental, domestic and occupational exposures during several periods of life Two blood samples will be collected at enrollment to study genetic polymorphisms<br>|
| Group B controls<br>Husbands of women with a pathological pregnancy | Other: Phone interview and blood test<br>* Subjects will be interviewed about environmental, domestic and occupational exposures during several periods of life Two blood samples will be collected at enrollment to study genetic polymorphisms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the association between pesticide exposure during Antenatal and Early Postnatal Periods and the risk of testicular cancer during adulthood | Occupational, environmental and domestic exposures to pesticides and other nuisances will be assessed. | at the end of enrollment (18 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the association between a combined exposure to pesticides and the risk of testicular cancer during adulthood | 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. | at the end of enrollment (18 months) | 
| Analyse polymorphisms known to be associated with testicular cancer risk to explore gene-environment interactions | Polymorphisms involved in organochlorine metabolism pathways will also be assessed. Biological study | one year after the end of enrollment |