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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 4 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.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
-
Hangzhou, China, 310000
- Zhejiang Provincial People's Hospital
-
Shanghai, China, 200000
- Shanghai Jiaotong University School of Medicine
-
Tianjin, China, 300000
- Tianjin Medical University Center Hospital
-
-
Jiangsu
-
Changzhou, Jiangsu, China, 213000
- The First Peple's Hospital of Changzhou
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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 3/4.
- The surgeon has confirmed surgical indication and the subject is willing to undergo the planned surgical intervention at the participating medical institution; or cytology results are benign, and the nodule(s) have remained clinically stable-defined as absence of new high-risk ultrasound features and no significant change in size on serial imaging.
- 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.
Exclusion Criteria:
- The subject has a history of thyroid tumor.
- The subject is not suitable for fine-needle aspiration biopsy and surgical treatment due to other conditions such as comorbid diseases.
- Subjects who intend to receive the radiofrequency ablation therapy.
- Other conditions determined by the researcher that do not meet the criteria of enrollment.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Ultrasound findings of thyroid nodules classified as type 3 and 4 of C-TIRADS
|
To evaluate the accuracy of Thyroscan in the differential diagnosis of benign and malignant thyroid nudules with abnormal ultrasound features.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
To evaluation of Thyroscan's performance in diagnosing thyroid nodules
Prazo: At the time of postsurgical pathology report, or upon completion of the 12-month follow-up for non-surgical participants.
|
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 3/4.
|
At the time of postsurgical pathology report, or upon completion of the 12-month follow-up for non-surgical participants.
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
To compared with cytopathology and Thyroscan in diagnosing thyroid nodules.
Prazo: At the time of postsurgical pathology report, or upon completion of the 12-month follow-up for non-surgical participants.
|
At the time of postsurgical pathology report, or upon completion of the 12-month follow-up for non-surgical participants.
|
Outras medidas de resultado
Medida de resultado |
Prazo |
|---|---|
|
To reveals the correlation between molecular landscape and clinical-pathological characteristics of thyroid nodules.
Prazo: At the time of postsurgical pathology report, or upon completion of the 12-month follow-up for non-surgical participants.
|
At the time of postsurgical pathology report, or upon completion of the 12-month follow-up for non-surgical participants.
|
Colaboradores e Investigadores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- RigenBio
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .