- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Minya Governorate
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Minya, Minya Governorate, Egipto, 61611
- Faculty of Medicine
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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• Incidence of incidental differentiated thyroid cancer with autoimmune thyroiditis
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of incidental differentiated thyroid cancer by autoimmune thyroiditis subtype
Periodo de tiempo: At time of surgery
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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
Periodo de tiempo: 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
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At time of surgery
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Outcome 3B: Sex distribution
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Neoplasias por sitio
- Neoplasias
- Enfermedades autoinmunes
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Neoplasias de tiroides
- Neoplasias de glándulas endocrinas
- Neoplasias de Cabeza y Cuello
- Neoplasias Glandulares y Epiteliales
- Adenocarcinoma
- Carcinoma
- Enfermedades de la tiroides
- Adenocarcinoma Papilar
- Tiroiditis
- Cáncer De Tiroides Papilar
- Adenocarcinoma Folicular
- Enfermedad de Hashimoto
- Tiroiditis Autoinmune
Otros números de identificación del estudio
- 1462/02/2025
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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