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

Léon Bérard Center

Status: Completed

Conditions: Testicular Germ Cell Tumor

Treatments: Other: Phone interview and blood test

Study type: Observational

Funder types: Other

Identifiers

NCT02109926

140184B-12 (Other Identifier)

TESTIS

ET14-004 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,367 patients

Sex: Male

Ages: 18 to 44 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

1,367 participants in 3 patient groups

Cases: testicular cancer patients

Treatment:

Other: Phone interview and blood test

Group A controls

Description:

Sperm donors and husbands of women with fertility disorders All controls must have a normal spermogram

Treatment:

Other: Phone interview and blood test

Group B controls

Description:

Husbands of women with a pathological pregnancy

Treatment:

Other: Phone interview and blood test