- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07611994
Analysis of Chlordecone Tissue Concentrations in Patients Treated for Thyroid Surgery at Guadeloupe University Hospital (COTICHLO)
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: mélanie petapermal, Master degree
- 전화번호: +590 +590590934667
- 이메일: melanie.petapermal@chu-guadeloupe.fr
연구 장소
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Les Abymes, 과들루프, 97159
- CHU de la Guadeloupe
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연락하다:
- suzy Duflo, MD PhD
- 이메일: suzy.duflo@chu-guadeloupe.fr
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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다른: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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chlordecone concentration in the adipose tissue adjacent to the thyroid
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Occupational exposure category
기간: At enrollment
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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 enrollment
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Residential environmental exposure assessment
기간: At enrollment
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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 enrollment
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Dietary exposure assessment
기간: At enrollment
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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 enrollment
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공동 작업자 및 조사자
수사관
- 수석 연구원: suzy Duflo, MD PhD, CHU de la Guadeloupe
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- PAP_RIPH2_2025/08
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Blood and thyroid tissue collection에 대한 임상 시험
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The University of QueenslandBecton, Dickinson and Company모병