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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02109926
Acronym
TESTIS
Enrollment
1367
Registered
2014-04-10
Start date
2015-01-31
Completion date
2018-04-30
Last updated
2018-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Testicular Germ Cell Tumor

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.

Interventions

OTHERPhone 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

Sponsors

National Cancer Institute, France
CollaboratorOTHER_GOV
Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
Centre Leon Berard
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 44 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Assess the association between pesticide exposure during Antenatal and Early Postnatal Periods and the risk of testicular cancer during adulthoodat the end of enrollment (18 months)Occupational, environmental and domestic exposures to pesticides and other nuisances will be assessed.

Secondary

MeasureTime frameDescription
Assess the association between a combined exposure to pesticides and the risk of testicular cancer during adulthoodat 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 interactionsone year after the end of enrollmentPolymorphisms involved in organochlorine metabolism pathways will also be assessed. Biological study

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026