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

May 9, 2018 updated by: Centre Leon Berard

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1367

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25030
        • CHRU Jean Minjoz
      • Bondy, France, 93140
        • CHU Jean VERDIER
      • Bordeaux, France, 33076
        • Maternité CHU Pellegrin
      • Bron, France, 69677
        • Hôpital Femme Mère Enfant
      • Caen, France, 14033
        • CHU de Caen
      • Clermont-Ferrand, France, 63003
        • CHU Estaing
      • Dijon, France, 21079
        • CHU Dijon
      • Grenoble, France, 38043
        • CHU de Grenoble - Hôpital Couple Enfants
      • Lille, France, 59037
        • CHRU Lille - Hopital Calmette
      • Lyon, France, 69008
        • Centre Leon Berard
      • Marseille, France, 13385
        • CHU la Conception
      • Montpellier, France, 34295
        • Hopital Arnaud de Villeneuve
      • Nancy, France, 74213
        • Maternité Université Régionale
      • Nice, France, 06202
        • CHU de Nice - Hopital L'Archet
      • Paris, France, 75020
        • Hopital Tenon
      • Paris, France, 75014
        • Hopital Cochin
      • Reims, France, 51092
        • Hôpital Maison Blanche
      • Rennes, France, 35200
        • CHU de Rennes - Hôpital Sud
      • Rouen, France, 76031
        • CHU Charles Nicolle
      • Schiltigheim, France, 67303
        • Centre Médico-Chirurgical Obstétrique
      • Toulouse, France, 31059
        • Hopital Paule de Viguier
      • Tours, France, 37000
        • CHU Bretonneau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

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
Group A controls
Sperm donors and husbands of women with fertility disorders All controls must have a normal spermogram
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
Group B controls
Husbands of women with a pathological pregnancy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at the end of enrollment (18 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at the end of enrollment (18 months)
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
one year after the end of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Leon Berard

Collaborators

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

Investigators

  • Principal Investigator: Béatrice FERVERS, MD, Centre Leon Berard
  • Study Director: Joachim SCHÜZ, PhD, International Agency for Research on Cancer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

March 30, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

April 8, 2014

First Submitted That Met QC Criteria

April 8, 2014

First Posted (Estimate)

April 10, 2014

Study Record Updates

Last Update Posted (Actual)

May 11, 2018

Last Update Submitted That Met QC Criteria

May 9, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TESTIS
  • ET14-004 (Other Identifier: Sponsor's number)
  • 140184B-12 (Other Identifier: ANSM's number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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