A Case-control Study to Assess the Association Between Environmental, Domestic and Occupational Exposures and the Risk of Testicular Germ Cell Tumor
- Conditions
- Testicular Germ Cell Tumor
- Interventions
- Other: Phone interview and blood test
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 1367
- 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
- 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
- Arm && Interventions
Group Intervention Description Cases: testicular cancer patients Phone interview and blood test - Group B controls Phone interview and blood test Husbands of women with a pathological pregnancy Group A controls Phone interview and blood test Sperm donors and husbands of women with fertility disorders All controls must have a normal spermogram
- 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)
CHU de Caen
馃嚝馃嚪Caen, France
CHU de Grenoble - H么pital Couple Enfants
馃嚝馃嚪Grenoble, France
CHRU Jean Minjoz
馃嚝馃嚪Besan莽on, France
CHU Jean Verdier
馃嚝馃嚪Bondy, France
Maternit茅 CHU Pellegrin
馃嚝馃嚪Bordeaux, France
H么pital Femme M猫re Enfant
馃嚝馃嚪Bron, France
CHU Estaing
馃嚝馃嚪Clermont-Ferrand, France
H么pital Cochin
馃嚝馃嚪Paris, France
CHU Dijon
馃嚝馃嚪Dijon, France
Centre L茅on B茅rard
馃嚝馃嚪Lyon, France
CHRU Lille - H么pital Calmette
馃嚝馃嚪Lille, France
CHU La Conception
馃嚝馃嚪Marseille, France
H么pital Arnaud de Villeneuve
馃嚝馃嚪Montpellier, France
Maternit茅 Universit茅 R茅gionale
馃嚝馃嚪Nancy, France
CHU de Nice - H么pital l'Archet
馃嚝馃嚪Nice, France
H么pital Tenon
馃嚝馃嚪Paris, France
H么pital Maison Blanche
馃嚝馃嚪Reims, France
CHU de Rennes - H么pital Sud
馃嚝馃嚪Rennes, France
CHU Charles Nicolle
馃嚝馃嚪Rouen, France
Centre M茅dico-Chirurgical Obst茅trique
馃嚝馃嚪Schiltigheim, France
CHU Bretonneau
馃嚝馃嚪Tours, France
H么pital Paule de Viguier
馃嚝馃嚪Toulouse, France