Analysis of Chlordecone Tissue Concentrations in Patients Treated for Thyroid Surgery at Guadeloupe University Hospital (COTICHLO)
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
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:mélanie petapermal, Master degree
- 电话号码:+590 +590590934667
- 邮箱:melanie.petapermal@chu-guadeloupe.fr
学习地点
-
-
-
Les Abymes、瓜德罗普岛、97159
- CHU de la Guadeloupe
-
接触:
- suzy Duflo, MD PhD
- 邮箱:suzy.duflo@chu-guadeloupe.fr
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
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
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
调查人员
- 首席研究员:suzy Duflo, MD PhD、CHU de la Guadeloupe
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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.