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NCT Number: NCT02986763

Evaluation of Pesticide Exposure in the General Population

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.

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Key information

Conditions

Pesticide Poisoning

Age range

18 year–65 year

Sex eligibility

Male

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire, blood, urine, hair and dust samplings

Biological

Primary outcomes

  1. level of pesticide exposures

    Time frame: up to 2 years

    environmental, occupational and domestic exposures

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Collaborators

  • Cancer Research Center of Lyon
  • Cancéropôle Lyon Auvergne Rhône-Alpes
  • International Agency for Research on Cancer
  • Rovaltain Research Company

Registry information

Official study title

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

Acronym: SIGEXPOSOME

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 8, 2016
Registry last updated
Feb 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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