Ignite Creation Date:
2024-05-06 @ 2:41 AM
Last Modification Date:
2024-10-26 @ 11:22 AM
Study NCT ID:
NCT02109926
Status:
COMPLETED
Last Update Posted:
2018-05-11
First Post:
2014-04-08
Brief Title:
A Case-control Study to Assess the Association Between Environmental Domestic and Occupational Exposures and the Risk of Testicular Germ Cell Tumor
Sponsor:
Centre Leon Berard
Organization:
Centre Leon Berard
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TESTIS
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 sparseThe 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 sons 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
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 sons 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
Detailed Description:
Environmental exposure to pesticides will be assessed from subjects 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ET14-004 | OTHER | None | None |
| 140184B-12 | OTHER | ANSMs number | None |