- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05025046
NGS-based Thyroscan Genomic Classifier in the Diagnosis of Thyroid Nodules
Prospective, Blinded, Multi-center Clincal Study of NGS-based Thyroscan Genomic Classifier in the Diagnosis of Thyroid Nodules
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The prevalence of thyroid nodules by high-resolution ultrasound can be as high as 20%, though most of them are benign lesions, only about 5%~15% are malignant lesions. Based on 1.4 billion population in China, there are approximately 280 million thyroid nodule carriers, of which approximately 14~42 million are potential patients with thyroid cancer. Now thyroid cancer is the fastest growing cancer and the 4th most common cancer in women in China. Therefore, the key point in the evaluation of thyroid nodules is the differential diagnosis of benign and malignant nodules. At present, the commonly used imaging and cytological diagnostic techniques for thyroid nodules include ultrasound and ultrasound-guided fine needle aspiration biopsy (FNAB), as well as emerging molecular diagnostic techniques.
The purpose of this study is to evaluate the accuracy of Thyroscan in the diagnosis of benign and malignant thyroid nodules with suspecious ultrasound features. For patients who have signed an informed consent, the subjects undergo fine needle aspiration of thyroid nodules classified as C-TIRADS catagories 3 or 4a under the guidance of ultrasound or palpation before receiving surgical treatment. One needle is used to prepare cytological smear, and one needle is preserved and sent to Thyroscan detection. The histopathological is obtained as the "gold standerd" after surgical treatment.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Liang Hanzi
- Número de teléfono: +8613895604662
- Correo electrónico: liang.hanzi@rigen-bio.com
Ubicaciones de estudio
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Guangzhou, Porcelana, 510000
- Aún no reclutando
- Guangdong Provincial People's Hospital
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Contacto:
- Guan Haixia
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Hangzhou, Porcelana, 310000
- Aún no reclutando
- Zhejiang Provincial People's Hospital
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Contacto:
- Zheng Chuanmin
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Shanghai, Porcelana, 200000
- Aún no reclutando
- Shanghai Jiaotong University School of Medicine
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Contacto:
- Wang Zhuoying
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Shenzhen, Porcelana, 518000
- Aún no reclutando
- Shenzhen People's Hospital
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Tianjin, Porcelana, 300000
- Reclutamiento
- Tianjin Medical University Center Hospital
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Contacto:
- Zheng Xiangqian
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Guangdong
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Zhongshan, Guangdong, Porcelana, 528400
- Aún no reclutando
- Zhongshan City People's Hospital
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Jiangsu
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Changzhou, Jiangsu, Porcelana, 213000
- Aún no reclutando
- The First Peple's Hospital of Changzhou
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Contacto:
- Li Qing
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patients sign the informed consent form for participating in the reasearch study.
- Patient's age is 18 years or older.
- Ultrasound showed at least one thyroid nodule, and it was classified as C-TIRADS Category 3/4a.
- The surgeon has evaluated the indications for surgery, and the subject is willing to receive surgical intervention in the medical institution.
- Surgical indications include but are not limited to one of the following conditions: 1) Thyroid nodules are compressed or affect aesthetics; 2) The patient's subjective wishes require surgical removal of the nodules; 3) FNA samples with indeterminate cytology are classified as Bethesda III and IV, requiring diagnostic surgery; 4) After the investigator's assessment, there are other surgical indications.
- Preoperative FNAB to obtain sufficient cells to meet FNA samples with indeterminate cytology are classified as Bethesda III and IV.
- The final pathological diagnosis is obtained after surgury.
Exclusion Criteria:
- The subject has a history of thyroid tumor.
- The subject has swollen lymph nodes in the central area or/and lateral neck area.
- The subject is not suitable for fine-needle aspiration biopsy and surgical treatment due to other conditions such as comorbid diseases.
- FNAB interprets the thyroid nodule as Bethesda V and VI categories.
- Subjects who intend to receive the radiofrequency ablation therapy.
- Other conditions determined by the researcher that do not meet the criteria of enrollment.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Ultrasound findings of thyroid nodules classified as type 3 and 4a of TIRADS
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To evaluate the accuracy of Thyroscan in the differential diagnosis of benign and malignant thyroid nudules with abnormal ultrasound features.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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To evaluation of Thyroscan's performance in diagnosing thyroid nodules
Periodo de tiempo: June,2022
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To explore the sensitivity, specificity, positive predictive value, negative predictive value, consistency and Kappa value of Thyroscan in the diagnosis of thyroid nodules with ultrasound features classified as C-TIRADS category 3/4a.
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June,2022
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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To compared with cytopathology and Thyroscan in diagnosing thyroid nodules.
Periodo de tiempo: June,2022
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June,2022
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To explore the inter-observer heterogeneity when reviewing fine needle aspiration biopsy(FNAB) by two senior cytopathologists.
Periodo de tiempo: June,2022
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June,2022
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Otras medidas de resultado
Medida de resultado |
Periodo de tiempo |
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To explore the cost-effectiveness analysis of Thyroscan.
Periodo de tiempo: June,2022
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June,2022
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To reveals the correlation between molecular landscape and clinical-pathological characteristics of thyroid nodules.
Periodo de tiempo: June,2022
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June,2022
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
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Información sobre medicamentos y dispositivos, documentos del estudio
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