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临床试验/NCT02442661
NCT02442661已完成不适用

Clinical Validation of a Predictive Model for the Presence of Cervical Lymph Node Metastasis in Papillary Thyroid Cancer

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
103
试验地点
1
主要终点
Detection of lymph node metastasis in a patient with Papillary Thyroid Cancer by neck ultrasound by radiologist's standard assessment method (Ir test).

研究概览

简要总结

This research study is performed to compare the accuracy of two methods of lymph node evaluation: research method versus standard method. Standard method is what is usually performed as standard of care where the radiologist evaluates the images overall and decides whether each node seen should or should not be biopsied. In the research method, a second radiologist will evaluate the ultrasound images of the lymph nodes separately, and use a small specific checklist of ultrasound appearance to determine whether each node should or should not be biopsied. Results of both the standard and research method will be used to decide which node(s), if any should be biopsied. Neck ultrasound examination, lymph node evaluation by standard method and subsequent lymph node biopsy are part of the standard clinical care. It is less likely but possible that the research method may identify additional lymph nodes for biopsy to check if that lymph node contains thyroid cancer.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of PTC and at least one sonographic examination of the cervical lymph nodes.
  • Patients can only be included in the study once. Thus, if they have two sonographic examinations, only one can be included in the study results.
  • All patients who fit the study criteria after the start of the study will be included, using the first sonographic exam as the study exam.

排除标准

  • Lymph node with oval shape, hypoechoic cortex, smooth border, hyperechoic hilum and hilar Doppler flow by ultrasound are considered to be normal and be excluded from FNAB per standard clinical practice.
  • Lymph node less than 5 mm in short axis on ultrasound.

结局指标

主要结局

Detection of lymph node metastasis in a patient with Papillary Thyroid Cancer by neck ultrasound by radiologist's standard assessment method (Ir test).

时间窗: 6 months

Detection of lymph node metastasis in a patient with Papillary Thyroid Cancer by neck ultrasound by predictive model method (Im test).

时间窗: 6 months

次要结局

  • Confirmation of the lymph node metastasis by fine needle aspiration biopsy prior to the surgery.(6 months)
  • Measure true positive and false positive results of Ir test and Im test for comparison.(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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