- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07652450
Incidental Thyroid Cancer in Cases With Inflammatory Thyroid Lesion (Thyroid cancer)
Incidental Thyroid Cancer in Patients With Inflammatory Thyroid Lesions: A Cohort Study From a Tertiary Care Center
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
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Minya Governorate
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Minya, Minya Governorate, Egypte, 61611
- Faculty of Medicine
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
All types of autoimmune thyroiditis, including:
- Graves' disease
- Toxic multinodular goiter (TMNG)
- Toxic nodule (TN)
- Hashimoto thyroiditis
- Unspecified toxic nodular goiter
- Age between 18 and 60 years
- Underwent thyroid surgical operation (lobectomy or total thyroidectomy)
Exclusion Criteria:
- Patients with known differentiated thyroid cancer before surgery
- Recurrent thyroid disease (previous thyroid surgery)
- Patients unfit for operation (American Society of Anesthesiologists grade IV or V)
- Incomplete histopathological data
- Patients with medullary thyroid carcinoma or anaplastic thyroid cancer
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: Inflammatory thyroid lesions
The presence of thyroiditis was determined considering histological diagnosis taken post-surgery, and we considered the correlation between any presence of thyroiditis and all Differentiated thyroid cancer, taken from the histopathological examination after pathologic analysis.
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Diagnosis of differentiated thyroid cancer: The presence of thyroid cancer was determined based on histopathological examination of the resected specimen
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
• Incidence of incidental differentiated thyroid cancer with autoimmune thyroiditis
Délai: At time of surgery (postoperative histopathology)
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Title: Incidence of incidental differentiated thyroid cancer Unit of measure: % of patients (proportion) Metric/method: Histopathological examination of surgical specimen |
At time of surgery (postoperative histopathology)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of incidental differentiated thyroid cancer by autoimmune thyroiditis subtype
Délai: At time of surgery
|
Unit of Measure Percentage of patients within each subtype (Hashimoto thyroiditis, Graves' disease, toxic nodular goiter) Metric / Method Histopathological classification of thyroiditis subtype and cancer diagnosis; comparison using Chi-square test or Fisher's exact test |
At time of surgery
|
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Outcome 3A: Age comparison
Délai: At time of surgery
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Outcome Measure Title Mean age difference between patients with and without incidental differentiated thyroid cancer Unit of Measure Years (mean ± standard deviation) Metric / Method Unpaired Student's t-test or Mann-Whitney U test
|
At time of surgery
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Outcome 3B: Sex distribution
Délai: Preoperative (within 30 days before surgery)
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Field Entry Outcome Measure Title Proportion of patients with positive anti-thyroid peroxidase (anti-TPO) antibodies who have incidental differentiated thyroid cancer Unit of Measure Percentage of patients Metric / Method Serological testing (anti-TPO antibodies measured by immunoassay); Chi-square test or logistic regression for association
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Preoperative (within 30 days before surgery)
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Secondary Outcome 4 - Tumor characteristics Outcome 4A: Tumor size
Délai: At time of surgery
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Outcome Measure Title Maximum tumor diameter in incidental differentiated thyroid cancers Unit of Measure Centimeters (mean ± standard deviation and range) Metric / Method Pathological measurement of surgical specimen
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At time of surgery
|
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Outcome 4B: Microcarcinoma proportion
Délai: At time of surgery
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Outcome Measure Title Proportion of incidental thyroid cancers that are microcarcinomas (≤1 cm) Unit of Measure Percentage of patients with incidental cancer Metric / Method Pathological measurement; defined as tumor size ≤1 cm
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At time of surgery
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Outcome 4C: Lymph node metastasis
Délai: At time of surgery
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Outcome Measure Title Proportion of patients with incidental differentiated thyroid cancer who have lymph node metastasis Unit of Measure Percentage of patients with incidental cancer Metric / Method Histopathological examination of central neck dissection specimens
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At time of surgery
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Outcome 4D: Multifocality
Délai: At time of surgery
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Outcome Measure Title Proportion of patients with incidental differentiated thyroid cancer who have multifocal disease Unit of Measure Percentage of patients with incidental cancer Metric / Method Histopathological examination (two or more distinct tumor foci)
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At time of surgery
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Outcome 3E: Extrathyroidal extension
Délai: At time of surgery
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Outcome Measure Title Proportion of patients with incidental differentiated thyroid cancer who have extrathyroidal extension Unit of Measure Percentage of patients with incidental cancer Metric / Method Histopathological examination (minimal or extensive extension)
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At time of surgery
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
- Maladies du système endocrinien
- Tumeurs par site
- Tumeurs
- Maladies auto-immunes
- Maladies du système immunitaire
- Tumeurs par type histologique
- Tumeurs thyroïdiennes
- Tumeurs des glandes endocrines
- Tumeurs de la tête et du cou
- Tumeurs, glandulaires et épithéliales
- Adénocarcinome
- Carcinome
- Maladies thyroïdiennes
- Adénocarcinome papillaire
- Thyroïdite
- Cancer de la thyroïde, papillaire
- Adénocarcinome folliculaire
- Maladie de Hashimoto
- Thyroïdite, auto-immune
Autres numéros d'identification d'étude
- 1462/02/2025
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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