Evaluation of Pesticide Exposure in the General Population

Pesticide Poisoning Clinical Trial

— SIGEXPOSOME  

Official title:

Evaluation of Pesticide Exposure in the General Population: Use of Spatial, Environmental, Toxicological and Biological Approaches

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02986763
• Other study ID #: SIGEXPOSOME
• Status: Completed
• Phase: N/A
• First received: November 30, 2016
• Last updated: February 8, 2018
• Start date: June 2015
• Est. completion date: March 2017

Study information

• Verified date: February 2018
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

An association has been suggested with several diseases including cancer and IARC has classified several pesticides as carcinogenic, probably carcinogenic. There is a need for a better characterisation of environmental pesticides exposures and identification of suitable biomarkers of exposure and effect. A better understanding of the impact of pesticide exposure on metabolomic, transcriptomic and epigenetic changes, is essential to strengthen epidemiological hypotheses on the association with several cancer types.

The main objective of the project is to validate a GIS (geographic information system) based method to assess environmental pesticide exposures, using environmental (contamination of housedust) and biological (blood and urine samples) measures. The project aims further to investigate a potential link between housedust contamination and biological measures in healthy non-smoking male residents and explore the impact of environmental pesticide exposure on metabolomics, transcriptomic and epigenetic parameters.

Description:

The project involves a pilot phase involving repeated (twice) sampling in 20 male non-smoking volunteers living in the Beaujolais region (France) to perform appropriate calibrations for metabolomic, transcriptomic and epigenetic analyses. The main study will be conducted in a sample of 150 male non-smoking volunteers and 50 professional pesticides applicators from the same region (3 sampling periods).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Non smokers in the last two years Living in the Beaujolais region (France) within 1000m of vignards Informed consent signed

Exclusion Criteria:

• Volunteers sharing the same households with professional applicators of pesticides

Related Conditions & MeSH terms

• Pesticide Poisoning
• Poisoning

Intervention

Biological:
• Questionnaire, blood, urine, hair and dust samplings

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Centre Leon Berard	Cancéropôle Lyon Auvergne Rhône-Alpes, Centre de rechercher en Cancérologie de Lyon, International Agency for Research on Cancer, Rovaltain Research Company

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	level of pesticide exposures	environmental, occupational and domestic exposures	up to 2 years