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Trial record 1 of 1 for:    16759991 [PUBMED-IDS]
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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 (TESTIS)

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ClinicalTrials.gov Identifier: NCT02109926
Recruitment Status : Completed
First Posted : April 10, 2014
Last Update Posted : May 10, 2018
Sponsor:
Collaborators:
National Cancer Institute, France
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Testicular Germ Cell Tumor Other: Phone interview and blood test

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.


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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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Biospecimen Retention:   Samples With DNA
plasma and buffy coat


Information from the National Library of Medicine

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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
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.

Criteria

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)

Information from the National Library of Medicine

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


Locations
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France
CHRU Jean Minjoz
Besançon, France, 25030
CHU Jean Verdier
Bondy, France, 93140
Maternité CHU Pellegrin
Bordeaux, France, 33076
Hôpital Femme Mère Enfant
Bron, France, 69677
CHU de Caen
Caen, France, 14033
CHU Estaing
Clermont-Ferrand, France, 63003
CHU Dijon
Dijon, France, 21079
CHU de Grenoble - Hôpital Couple Enfants
Grenoble, France, 38043
CHRU Lille - Hôpital Calmette
Lille, France, 59037
Centre Léon Bérard
Lyon, France, 69008
CHU La Conception
Marseille, France, 13385
Hôpital Arnaud de Villeneuve
Montpellier, France, 34295
Maternité Université Régionale
Nancy, France, 74213
CHU de Nice - Hôpital l'Archet
Nice, France, 06202
Hôpital Cochin
Paris, France, 75014
Hôpital Tenon
Paris, France, 75020
Hôpital Maison Blanche
Reims, France, 51092
CHU de Rennes - Hôpital Sud
Rennes, France, 35200
CHU Charles Nicolle
Rouen, France, 76031
Centre Médico-Chirurgical Obstétrique
Schiltigheim, France, 67303
Hôpital Paule de Viguier
Toulouse, France, 31059
CHU Bretonneau
Tours, France, 37000
Sponsors and Collaborators
Centre Leon Berard
National Cancer Institute, France
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Béatrice FERVERS, MD Centre Leon Berard
Study Director: Joachim SCHÜZ, PhD International Agency for Research on Cancer

Publications:

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Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT02109926     History of Changes
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 10, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
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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
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders