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

Completed

• Conditions: Testicular Germ Cell Tumor

• Registration Number: NCT02109926
• Lead Sponsor: Centre Leon Berard

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 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.

Study Timeline

• Study First Submitted: 2014-04-08
• Study First Submitted QC: 2014-04-08
• Study First Posted: 2014-04-10
• Study Start: 2015-01
• Primary Completion: 2018-03-30
• Study Completion: 2018-04
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-09
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1367

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Assess the association between a combined exposure to pesticides and the risk of testicular cancer during adulthood	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	one year after the end of enrollment	Polymorphisms involved in organochlorine metabolism pathways will also be assessed.; Biological study

Trial Locations

Locations (22)

CHRU Jean Minjoz; 🇫🇷 Besançon, France

CHU Jean Verdier; 🇫🇷 Bondy, France

Maternité CHU Pellegrin; 🇫🇷 Bordeaux, France

Hôpital Femme Mère Enfant; 🇫🇷 Bron, France

CHU de Caen; 🇫🇷 Caen, France

CHU Estaing; 🇫🇷 Clermont-Ferrand, France

CHU Dijon; 🇫🇷 Dijon, France

CHU de Grenoble - Hôpital Couple Enfants; 🇫🇷 Grenoble, France

CHRU Lille - Hôpital Calmette; 🇫🇷 Lille, France

Centre Léon Bérard; 🇫🇷 Lyon, France

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