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

NCT02109926 | Completed

• 3 other identifiers: TESTISET14-004140184B-12
• Study Type: observational
• Target: 1,367
• Locations: 1 country
• Sites: 22

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.

Conditions

Testicular Germ Cell Tumor

Outcome Measures

Primary Outcomes (1)

• Assess the association between pesticide exposure during Antenatal and Early Postnatal Periods and the risk of testicular cancer during adulthood

  Occupational, environmental and domestic exposures to pesticides and other nuisances will be assessed.

  at the end of enrollment (18 months)

Secondary Outcomes (2)

• Assess the association between a combined exposure to pesticides and the risk of testicular cancer during adulthood

  at the end of enrollment (18 months)

• Analyse polymorphisms known to be associated with testicular cancer risk to explore gene-environment interactions

  one year after the end of enrollment

Study Arms (3)

Cases: testicular cancer patients

Other: Phone interview and blood test

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

Group B controls

Husbands of women with a pathological pregnancy

Other: Phone interview and blood test

Interventions

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

Cases: testicular cancer patients; Group A controls; Group B controls

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Who has a legal guardian
• History of testicular germ cell tumor or cryptorchidism (only for controls)

Sponsors & Collaborators

• Centre Leon Berard: lead
• National Cancer Institute, France: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (22)

CHRU Jean Minjoz

Besançon, 25030, France

Location

CHU Jean Verdier

Bondy, 93140, France

Location

Maternité CHU Pellegrin

Bordeaux, 33076, France

Location

Hôpital Femme Mère Enfant

Bron, 69677, France

Location

CHU de Caen

Caen, 14033, France

Location

CHU Estaing

Clermont-Ferrand, 63003, France

Location

CHU Dijon

Dijon, 21079, France

Location

CHU de Grenoble - Hôpital Couple Enfants

Grenoble, 38043, France

Location

CHRU Lille - Hôpital Calmette

Lille, 59037, France

Location

Centre Léon Bérard

Lyon, 69008, France

Location

CHU La Conception

Marseille, 13385, France

Location

Hôpital Arnaud de Villeneuve

Montpellier, 34295, France

Location

Maternité Université Régionale

Nancy, 74213, France

Location

CHU de Nice - Hôpital l'Archet

Nice, 06202, France

Location

Hôpital Cochin

Paris, 75014, France

Location

Hôpital Tenon

Paris, 75020, France

Location

Hôpital Maison Blanche

Reims, 51092, France

Location

CHU de Rennes - Hôpital Sud

Rennes, 35200, France

Location

CHU Charles Nicolle

Rouen, 76031, France

Location

Centre Médico-Chirurgical Obstétrique

Schiltigheim, 67303, France

Location

Hôpital Paule de Viguier

Toulouse, 31059, France

Location

CHU Bretonneau

Tours, 37000, France

Location

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Biospecimen

Retention: SAMPLES WITH DNA

plasma and buffy coat

MeSH Terms

Conditions

Testicular Germ Cell Tumor

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Béatrice FERVERS, MD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

• Joachim SCHÜZ, PhD

  International Agency for Research on Cancer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 10, 2014
• Study Start: January 1, 2015
• Primary Completion: March 30, 2018
• Study Completion: April 1, 2018
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

FR (22)