- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07611994
Analysis of Chlordecone Tissue Concentrations in Patients Treated for Thyroid Surgery at Guadeloupe University Hospital (COTICHLO)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: mélanie petapermal, Master degree
- Numéro de téléphone: +590 +590590934667
- E-mail: melanie.petapermal@chu-guadeloupe.fr
Lieux d'étude
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Les Abymes, Guadeloupe, 97159
- CHU de la Guadeloupe
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Contact:
- suzy Duflo, MD PhD
- E-mail: suzy.duflo@chu-guadeloupe.fr
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Autre: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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chlordecone concentration in the adipose tissue adjacent to the thyroid
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Occupational exposure category
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: suzy Duflo, MD PhD, CHU de la Guadeloupe
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PAP_RIPH2_2025/08
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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