CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,367 enrolled
Drug / intervention
Phone interview and blood testother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02109926
NCT02109926N/ACompleted

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

Centre Leon Berard·observational·Posted Apr 10, 2014·Updated May 11, 2018

In Brief

An observational study evaluating Phone interview and blood test for Testicular Germ Cell Tumor. Completed, enrolled 1,367 participants across 22 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFrance

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 10, 2014
Enrollment StartJan 1, 2015
Primary CompletionMar 30, 2018
Study CompletionApr 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 12.2 years ago

Interventions

Phone interview and blood testother

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