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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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

69

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
chlordecone concentration in the adipose tissue adjacent to the thyroid
大体时间:During surgery
Chlordecone concentration measured in adipose tissue adjacent to the thyroid collected during thyroid surgery.
During surgery
Chlordecone concentration in blood
大体时间:1 day before surgery
Chlordecone concentration measured in blood samples collected one day before surgery.
1 day before surgery

次要结果测量

结果测量
措施说明
大体时间
Occupational exposure category
大体时间:At enrollment
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 enrollment
Residential environmental exposure assessment
大体时间:At enrollment
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 enrollment
Dietary exposure assessment
大体时间:At enrollment
Dietary habits assessed using a self-administered questionnaire collecting information on food consumption patterns and food origin.
At enrollment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:suzy Duflo, MD PhD、CHU de la Guadeloupe

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2027年11月1日

研究完成 (估计的)

2027年11月1日

研究注册日期

首次提交

2026年5月21日

首先提交符合 QC 标准的

2026年5月21日

首次发布 (实际的)

2026年5月28日

研究记录更新

最后更新发布 (实际的)

2026年6月1日

上次提交的符合 QC 标准的更新

2026年5月28日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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