SIGEXPOSOME: Evaluation of Pesticide Exposure in the General Population

Sponsor
Centre Leon Berard (Other)
Overall Status
Completed
CT.gov ID
NCT02986763
Collaborator
Cancéropôle Lyon Auvergne Rhône-Alpes (Other), International Agency for Research on Cancer (Other), Rovaltain Research Company (Other), Centre de rechercher en Cancérologie de Lyon (Other)
166
21

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Questionnaire, blood, urine, hair and dust samplings

Detailed 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).

Study Design

Study Type:
Observational
Actual Enrollment :
166 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Evaluation of Pesticide Exposure in the General Population: Use of Spatial, Environmental, Toxicological and Biological Approaches
Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Mar 1, 2017
Actual Study Completion Date :
Mar 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Professional pesticides

A specific questionnaire with professional information about pesticide uses is added for this arm Questionnaire to collect domestic pesticide use, diet, household characteristics Dust sampling Blood sampling Urine sampling Hair sampling

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

Volunteers

Questionnaire to collect domestic pesticide use, diet, household characteristics Dust sampling Blood sampling Urine sampling Hair sampling

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

Outcome Measures

Primary Outcome Measures

  1. level of pesticide exposures [up to 2 years]

    environmental, occupational and domestic exposures

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT02986763
Other Study ID Numbers:
  • SIGEXPOSOME
First Posted:
Dec 8, 2016
Last Update Posted:
Feb 9, 2018
Last Verified:
Feb 1, 2018
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 9, 2018