- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07611994
Analysis of Chlordecone Tissue Concentrations in Patients Treated for Thyroid Surgery at Guadeloupe University Hospital (COTICHLO)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Chlordecone, an organochlorine pesticide, is recognized as an endocrine disruptor. Following ingestion, this molecule is preferentially stored in the liver and, to a lesser extent, in adipose tissue. The development of thyroid goiter may be promoted by exposure to certain substances. Environmental pollutants have been shown to increase TSH secretion, and prolonged exposure to endocrine disruptors affecting the pituitary-thyroid axis has been associated with thyroid neoplasia.
Currently, exposure to chlordecone is assessed through measurement of chlordeconemia (plasma concentration), reflecting exposure during the months preceding sampling and providing an estimate of body burden at the time of assessment. However, chlordecone impregnation in thyroid tissue and adjacent structures has not yet been investigated in humans.
The aim of this study is to model chlordecone concentration in tissues using chlordeconemia, occupational activity, dietary habits, and place of residence.
A biological collection will be established and stored at the Biological Resources Center (CRB) of the University Hospital to support the primary and secondary objectives. Blood, adipose tissue, and thyroid tissue samples will be collected.
The inclusion period will last 11 months, each participant will be involved for 4 months, and the total study duration will be 16 months.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: mélanie petapermal, Master degree
- Phone Number: +590 +590590934667
- Email: melanie.petapermal@chu-guadeloupe.fr
Study Locations
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-
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Les Abymes, Guadeloupe, 97159
- CHU de la Guadeloupe
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Contact:
- suzy Duflo, MD PhD
- Email: suzy.duflo@chu-guadeloupe.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- adult patients hospitalized at the Guadeloupe University Hospital for surgical treatment of thyroid pathology
- person affiliated to or beneficiaries of a social security system
- person with free, informed, and written consent signed by the participant and the investigator
Exclusion Criteria:
- patients subject to a judicial safeguard measure,
- patient under 18 years old
- patient without signed consent
- current pregnancy at the time of inclusion
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Participants undergoing thyroid surgery
Participants undergoing thyroid surgery with prospective collection of blood, thyroid tissue, and adjacent adipose tissue samples for chlordecone concentration assessment and evaluation of exposure-related factors.
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Collection of blood, thyroid tissue, and adjacent adipose tissue samples during routine thyroid surgery for measurement of chlordecone concentration and assessment of exposure-related factors.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
chlordecone concentration in the adipose tissue adjacent to the thyroid
Time Frame: During surgery
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Chlordecone concentration measured in adipose tissue adjacent to the thyroid collected during thyroid surgery.
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During surgery
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Chlordecone concentration in blood
Time Frame: 1 day before surgery
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Chlordecone concentration measured in blood samples collected one day before surgery.
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1 day before surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Occupational exposure category
Time Frame: At inclusion
|
Occupational activity classified as high or low potential exposure to chlordecone based on professional activity collected through a self-administered questionnaire.
Agricultural workers and livestock breeders will be classified as high exposure occupations
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At inclusion
|
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Residential environmental exposure assessment
Time Frame: At inclusion
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Environmental exposure assessment based on residential history during the previous 10 years.
Residential addresses reported for periods longer than 3 months will be geolocated and linked to soil contamination maps established by CIRAD.
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At inclusion
|
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Dietary exposure assessment
Time Frame: At inclusion
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Dietary habits assessed using a self-administered questionnaire collecting information on food consumption patterns and food origin.
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At inclusion
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: suzy Duflo, MD PhD, CHU de la Guadeloupe
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PAP_RIPH2_2025/08
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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