NCT02109926

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,367 (actual)
• Sponsor: Centre Leon Berard · Academic / Other
• Sex: Male
• Age: 18 Years – 44 Years
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Testicular Germ Cell Tumor

Interventions

Type	Name	Description
OTHER	Phone interview and blood test	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

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-03-30
• Completion: 2018-04-01
• First posted: 2014-04-10
• Last updated: 2018-05-11

Locations

22 sites across 1 country: France