NCT02986763

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 8, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

February 9, 2018

Status Verified

February 1, 2018

Enrollment Period

1.8 years

First QC Date

November 30, 2016

Last Update Submit

February 8, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • level of pesticide exposures

    environmental, occupational and domestic exposures

    up to 2 years

Study Arms (2)

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

Interventions

Professional pesticidesVolunteers

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers living in the Beaujolais region (France)

You may qualify if:

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

You may not qualify if:

  • Volunteers sharing the same households with professional applicators of pesticides

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Surveys and QuestionnairesBlood Specimen CollectionUrination

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeUrinary Tract Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2016

First Posted

December 8, 2016

Study Start

June 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

February 9, 2018

Record last verified: 2018-02