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Completed

NCT Number: NCT02109926

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

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.

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Key information

Conditions

Testicular Germ Cell Tumor

Age range

18 year–44 year

Sex eligibility

Male

Study type

Observational

Primary location

CHRU Jean Minjoz, Besançon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Phone interview and blood test

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France
  • National Cancer Institute, France

Registry information

Official study 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

Acronym: TESTIS

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 10, 2014
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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