Clinical trial NCT02109926: A Case-control Study to Assess the Association Between Environmental, Domestic and Occupational Exposures and the Risk of Testicular Germ Cell Tumor
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Testicular Germ Cell Tumor
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2014-04-10
Enrollment: 1367
Sex: MALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases are patients with a testicular germ cell tumor. They will be recruited in the French infertility centers at the moment of sperm cryopreservation.

Group A controls are sperm donors and husbands of women with fertility troubles. They will be recruited in the French infertility centers and in the medically assisted procreation centers.

Group B controls are husbands of women followed for a pathological pregnancy. This group of controls will be recruited in the level III maternities.

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.

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)

Primary outcomes:
measure: Assess the association between pesticide exposure during Antenatal and Early Postnatal Periods and the risk of testicular cancer during adulthood
timeFrame: at the end of enrollment (18 months)
Secondary outcomes:
measure: Assess the association between a combined exposure to pesticides and the risk of testicular cancer during adulthood
timeFrame: at the end of enrollment (18 months)
measure: Analyse polymorphisms known to be associated with testicular cancer risk to explore gene-environment interactions
timeFrame: one year after the end of enrollment
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHRU Jean Minjoz
city: Bondy
country: France
facility: CHU Jean Verdier
city: Bordeaux
country: France
facility: Maternité CHU Pellegrin
city: Bron
country: France
facility: Hôpital Femme Mère Enfant
city: Caen
country: France
facility: CHU de Caen
city: Clermont-Ferrand
country: France
facility: CHU Estaing
city: Dijon
country: France
facility: CHU Dijon
city: Grenoble
country: France
facility: CHU de Grenoble - Hôpital Couple Enfants
city: Lille
country: France
facility: CHRU Lille - Hôpital Calmette
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: CHU La Conception
city: Montpellier
country: France
facility: Hôpital Arnaud de Villeneuve
city: Nancy
country: France
facility: Maternité Université Régionale
city: Nice
country: France
facility: CHU de Nice - Hôpital l'Archet
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital Tenon
city: Reims
country: France
facility: Hôpital Maison Blanche
city: Rennes
country: France
facility: CHU de Rennes - Hôpital Sud
city: Rouen
country: France
facility: CHU Charles Nicolle
city: Schiltigheim
country: France
facility: Centre Médico-Chirurgical Obstétrique
city: Toulouse
country: France
facility: Hôpital Paule de Viguier
city: Tours
country: France
facility: CHU Bretonneau
Study officials:
affiliation: Centre Leon Berard
name: Béatrice FERVERS, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Agency for Research on Cancer
name: Joachim SCHÜZ, PhD
role: STUDY_DIRECTOR
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