A Case-control Study to Assess the Association Between Environmental, Domestic and Occupational Exposures and the Risk of Testicular Germ Cell Tumor (TESTIS)
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| ClinicalTrials.gov Identifier: NCT02109926 |
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Recruitment Status :
Completed
First Posted : April 10, 2014
Last Update Posted : May 11, 2018
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Testicular Germ Cell Tumor | Other: Phone interview and blood test |
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 Type : | Observational |
| Actual Enrollment : | 1367 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Retrospective |
| 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 Start Date : | January 2015 |
| Actual Primary Completion Date : | March 30, 2018 |
| Actual Study Completion Date : | April 2018 |
| Group/Cohort | Intervention/treatment |
|---|---|
| Cases: testicular cancer patients |
Other: 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 |
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Group A controls
Sperm donors and husbands of women with fertility disorders All controls must have a normal spermogram
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Other: 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 |
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Group B controls
Husbands of women with a pathological pregnancy
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Other: 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 |
- Assess the association between pesticide exposure during Antenatal and Early Postnatal Periods and the risk of testicular cancer during adulthood [ Time Frame: at the end of enrollment (18 months) ]Occupational, environmental and domestic exposures to pesticides and other nuisances will be assessed.
- Assess the association between a combined exposure to pesticides and the risk of testicular cancer during adulthood [ Time Frame: 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 [ Time Frame: one year after the end of enrollment ]
Polymorphisms involved in organochlorine metabolism pathways will also be assessed.
Biological study
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | 18 Years to 44 Years (Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02109926
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| Principal Investigator: | Béatrice FERVERS, MD | Centre Leon Berard | |
| Study Director: | Joachim SCHÜZ, PhD | International Agency for Research on Cancer |
| Responsible Party: | Centre Leon Berard |
| ClinicalTrials.gov Identifier: | NCT02109926 |
| Other Study ID Numbers: |
TESTIS ET14-004 ( Other Identifier: Sponsor's number ) 140184B-12 ( Other Identifier: ANSM's number ) |
| First Posted: | April 10, 2014 Key Record Dates |
| Last Update Posted: | May 11, 2018 |
| Last Verified: | May 2018 |
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Neoplasms, Germ Cell and Embryonal Testicular Neoplasms Neoplasms by Histologic Type Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Genital Diseases Urogenital Diseases Male Urogenital Diseases Endocrine System Diseases Testicular Diseases Gonadal Disorders |