Establishment of Scoring Model for Early and Differential Diagnosis of Intrahepatic Cholangiocarcinoma
2022年4月7日 更新者：Yanjing Gao、Qilu Hospital of Shandong University
Establishment of Scoring Model for Early Diagnosis and Differential Diagnosis of Intrahepatic Cholangiocarcinoma
The purpose of this study is to develop and validate a radiological nomogram including radiological characteristics, clinical risk factors, and medical history.
And we aim to establish a noninvasive method for the diagnosis of intrahepatic cholangiocarcinoma (ICC), and to construct a differential diagnosis model for ICC and hepatocellular carcinoma (HCC) with higher sensitivity and accuracy.
研究概览
地位
招聘中
条件
详细说明
In recent years, the incidence and mortality of intrahepatic cholangiocarcinoma (ICC) have been increasing worldwide.
Due to the different treatment options for hepatocellular carcinoma (HCC) and ICC, accurate differential diagnosis is critical for subsequent treatment of patients.
However, because of their similar CT image enhancement patterns, they are easily misdiagnosed by clinicians, leading to an incorrect treatment.
Based on the above research background, our objective is to establish a noninvasive method for the diagnosis of ICC and and to construct a differential diagnosis model for ICC and HCC with higher sensitivity and accuracy.
研究类型
观察性的
注册 (预期的)
300
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Yanjing Gao, PhD.MD
- 电话号码：86-18560086087
- 邮箱：gaoyanjing@sdu.edu.cn
学习地点
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Shandong
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Jinan、Shandong、中国、250012
- 招聘中
- Department of Gastroenterology,Qilu Hospital,Shandong University
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接触：
- Yanjing Gao, PhD.MD
- 电话号码：86-18560086087
- 邮箱：gaoyanjing@sdu.edu.cn
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Clinical data of patients in hospitals in the past 10 years were retrospectively collected.
Pathological database from September 2010 to July 2021 was searched.
Patients with definite pathological diagnosis of ICC or HCC were determined as the training group, and patients from September 2021 to September 2023 were prospectively collected as the validation group.
描述
Inclusion Criteria:
- patients with pathological confirmation of ICC or HCC,
- CT was performed less than 15 days before surgery,
- Patients with complete clinical data.
Exclusion Criteria:
- history of other tumors,
- Metastatic liver cancer,
- Patients received preoperative chemotherapy or radiotherapy,
- Image quality analysis is not ideal.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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Training cohort
Training cohort consists of the patients diagnosed with intrahepatic cholangiocarcinoma who collected from January 2010 to July 2021 retrospectively.
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Internal validation cohort
Internal validation cohort consists of the intrahepatic cholangiocarcinoma patients who enrolled from September 2021 of Qilu Hospital prospectively.
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External validation cohort
External validation cohort consists of the intrahepatic cholangiocarcinoma patients who enrolled from September 2021 of Shandong Province Hospital, Jinan Military General Hospital and Jinan Central Hospital prospectively.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Accuracy
大体时间：through study completion, up to 2 years
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The golden standard is the pathological biopsy.Compare the accuracy of the noninvasive model with the pathological biopsy.
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through study completion, up to 2 years
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sensitivity
大体时间：through study completion, up to 2 years
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Sensitivity of noninvasive model for diagnosis of intrahepatic cholangiocarcinoma.
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through study completion, up to 2 years
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specificity
大体时间：through study completion, up to 2 years
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Specificity of noninvasive model for diagnosis of intrahepatic cholangiocarcinoma.
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through study completion, up to 2 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Yanjing Gao, PhD.MD、Qilu Hospital, Shandong University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年11月22日
初级完成 (预期的)
2023年2月22日
研究完成 (预期的)
2023年5月22日
研究注册日期
首次提交
2022年4月7日
首先提交符合 QC 标准的
2022年4月7日
首次发布 (实际的)
2022年4月14日
研究记录更新
最后更新发布 (实际的)
2022年4月14日
上次提交的符合 QC 标准的更新
2022年4月7日
最后验证
2022年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.