Evaluation of Pesticide Exposure in the General Population

NCT ID: NCT02986763

Last Updated: 2018-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

166 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-03-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Pesticide Poisoning

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

Questionnaire, blood, urine, hair and dust samplings

Intervention Type BIOLOGICAL

Volunteers

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

Questionnaire, blood, urine, hair and dust samplings

Intervention Type BIOLOGICAL

Interventions

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Questionnaire, blood, urine, hair and dust samplings

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cancéropôle Lyon Auvergne Rhône-Alpes

OTHER

Sponsor Role collaborator

International Agency for Research on Cancer

OTHER

Sponsor Role collaborator

Rovaltain Research Company

UNKNOWN

Sponsor Role collaborator

Centre de rechercher en Cancérologie de Lyon

UNKNOWN

Sponsor Role collaborator

Centre Leon Berard

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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SIGEXPOSOME

Identifier Type: -

Identifier Source: org_study_id

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