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

NCT ID: NCT02109926

Last Updated: 2018-05-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1367 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2018-04-30

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.

Conditions

Testicular Germ Cell Tumor

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Cases: testicular cancer patients

Phone interview and blood test

Intervention Type: OTHER

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

Group A controls

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

Phone interview and blood test

Intervention Type: OTHER

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

Group B controls

Husbands of women with a pathological pregnancy

Phone interview and blood test

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute, France

OTHER_GOV

Sponsor Role: collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

Centre Leon Berard

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Béatrice FERVERS, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Leon Berard

Joachim SCHÜZ, PhD

Role: STUDY_DIRECTOR

International Agency for Research on Cancer

Locations

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

CHU La Conception

Marseille, , France

Hôpital Arnaud de Villeneuve

Montpellier, , France

Maternité Université Régionale

Nancy, , France

CHU de Nice - Hôpital l'Archet

Nice, , France

Hôpital Cochin

Paris, , France

Hôpital Tenon

Paris, , France

Hôpital Maison Blanche

Reims, , France

CHU de Rennes - Hôpital Sud

Rennes, , France

CHU Charles Nicolle

Rouen, , France

Centre Médico-Chirurgical Obstétrique

Schiltigheim, , France

Hôpital Paule de Viguier

Toulouse, , France

CHU Bretonneau

Tours, , France

Countries

France

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Other Identifiers

ET14-004

Identifier Type: OTHER

Identifier Source: secondary_id

140184B-12

Identifier Type: OTHER

Identifier Source: secondary_id

TESTIS

Identifier Type: -

Identifier Source: org_study_id