Pesticide PoisoningSIGEXPOSOMENCT02986763
Evaluation of Pesticide Exposure in the General Population
An observational study of Pesticide Poisoning, run by Centre Leon Berard.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pesticide Poisoning
- What is being tested?
- Questionnaire, blood, urine, hair and dust samplings
- How many people
- 166 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers living in the Beaujolais region (France)
Who may be able to join
- Non smokers in the last two years Living in the Beaujolais region (France) within 1000m of vignards Informed consent signed
Who cannot join
- Volunteers sharing the same households with professional applicators of pesticides
About this study
Official title: 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.
Read the 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).
- Conditions
- Pesticide Poisoning
- Being tested
- Questionnaire, blood, urine, hair and dust samplings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire, blood, urine, hair and dust samplingsBiological
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Biological: Questionnaire, blood, urine, hair and dust samplings |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of pesticide exposures
environmental, occupational and domestic exposures
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startJun 2015
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pesticide PoisoningStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Collaborators
- Cancéropôle Lyon Auvergne Rhône-Alpes, International Agency for Research on Cancer, Rovaltain Research Company, Cancer Research Center of Lyon
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986763
- Sponsor's protocol ID
- SIGEXPOSOME
- Acronym
- SIGEXPOSOME
- Status last verified
- Feb 2018
- First submitted
- 30 Nov 2016
- Last updated
- 9 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pesticide Exposure in the General Population: Use of Spatial, Environmental, Toxicological and Biological Approaches
- ClinicalTrials.gov ID
- NCT02986763
- Acronym / sponsor ID
- SIGEXPOSOME / SIGEXPOSOME
- Conditions
- Pesticide Poisoning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Collaborators
- Cancéropôle Lyon Auvergne Rhône-Alpes, International Agency for Research on Cancer, Rovaltain Research Company, Cancer Research Center of Lyon
- Study start
- Jun 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 8 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Professional pesticides | – | Biological: Questionnaire, blood, urine, hair and dust samplingsA 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 |
| Volunteers | – | Biological: Questionnaire, blood, urine, hair and dust samplingsQuestionnaire to collect domestic pesticide use, diet, household characteristics Dust sampling Blood sampling Urine sampling Hair sampling |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers living in the Beaujolais region (France)
Key inclusion criteria (1 listed)
- Non smokers in the last two years Living in the Beaujolais region (France) within 1000m of vignards Informed consent signed
Key exclusion criteria (1 listed)
- Volunteers sharing the same households with professional applicators of pesticides
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire, blood, urine, hair and dust samplings | Biological | Professional pesticides, Volunteers |
Primary outcome
level of pesticide exposures
Time frame: up to 2 years
environmental, occupational and domestic exposures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pesticide Poisoning, run by Centre Leon Berard.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of pesticide exposures (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2018.