Analysis of Chlordecone Tissue Concentrations in Patients Treated for Thyroid Surgery at Guadeloupe University Hospital (COTICHLO)

Chlordecone, an organochlorine pesticide used in the French Caribbean for several decades, is recognized as an endocrine disruptor. Accumulation in thyroid tissue may be modeled using several factors, including blood chlordecone levels, environmental exposure associated with place of residence, and dietary habits.

Study Overview

Status

Not yet recruiting

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

Interventional

Enrollment (Estimated)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.

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
Chlordecone concentration measured in adipose tissue adjacent to the thyroid collected during thyroid surgery.
During surgery
Chlordecone concentration in blood
Time Frame: 1 day before surgery
Chlordecone concentration measured in blood samples collected one day before surgery.
1 day before surgery

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
At inclusion
Residential environmental exposure assessment
Time Frame: At inclusion
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.
At inclusion
Dietary exposure assessment
Time Frame: At inclusion
Dietary habits assessed using a self-administered questionnaire collecting information on food consumption patterns and food origin.
At inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: suzy Duflo, MD PhD, CHU de la Guadeloupe

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

May 21, 2026

First Submitted That Met QC Criteria

May 21, 2026

First Posted (Actual)

May 28, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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