Analysis of Chlordecone Tissue Concentrations in Patients Treated for Thyroid Surgery at Guadeloupe University Hospital (COTICHLO)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: mélanie petapermal, Master degree
- Numero di telefono: +590 +590590934667
- Email: melanie.petapermal@chu-guadeloupe.fr
Luoghi di studio
-
-
-
Les Abymes, Guadalupa, 97159
- CHU de la Guadeloupe
-
Contatto:
- suzy Duflo, MD PhD
- Email: suzy.duflo@chu-guadeloupe.fr
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Altro: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
chlordecone concentration in the adipose tissue adjacent to the thyroid
Lasso di tempo: During surgery
|
Chlordecone concentration measured in adipose tissue adjacent to the thyroid collected during thyroid surgery.
|
During surgery
|
|
Chlordecone concentration in blood
Lasso di tempo: 1 day before surgery
|
Chlordecone concentration measured in blood samples collected one day before surgery.
|
1 day before surgery
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Occupational exposure category
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: At enrollment
|
Dietary habits assessed using a self-administered questionnaire collecting information on food consumption patterns and food origin.
|
At enrollment
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: suzy Duflo, MD PhD, CHU de la Guadeloupe
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PAP_RIPH2_2025/08
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .