Evaluation of Pesticide Exposure in the General Population (SIGEXPOSOME)

February 8, 2018 updated by: Centre Leon Berard

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

166

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Healthy volunteers living in the Beaujolais region (France)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
level of pesticide exposures
Time Frame: up to 2 years
environmental, occupational and domestic exposures
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Leon Berard

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

November 30, 2016

First Submitted That Met QC Criteria

December 6, 2016

First Posted (Estimate)

December 8, 2016

Study Record Updates

Last Update Posted (Actual)

February 9, 2018

Last Update Submitted That Met QC Criteria

February 8, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIGEXPOSOME

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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