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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05327907
Other study ID # 202135719-Qilu
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 22, 2020
Est. completion date May 22, 2023

Study information

Verified date April 2022
Source Qilu Hospital of Shandong University
Contact Yanjing Gao, PhD.MD
Phone 86-18560086087
Email gaoyanjing@sdu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date May 22, 2023
Est. primary completion date February 22, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: 1. patients with pathological confirmation of ICC or HCC, 2. CT was performed less than 15 days before surgery, 3. Patients with complete clinical data. Exclusion Criteria: 1. history of other tumors, 2. Metastatic liver cancer, 3. Patients received preoperative chemotherapy or radiotherapy, 4. Image quality analysis is not ideal.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Department of Gastroenterology,Qilu Hospital,Shandong University Jinan Shandong

Sponsors (4)

Lead Sponsor Collaborator
Qilu Hospital of Shandong University Jinan Central Hospital, Jinan Military General Hospital, Shandong Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Accuracy The golden standard is the pathological biopsy.Compare the accuracy of the noninvasive model with the pathological biopsy. through study completion, up to 2 years
Primary sensitivity Sensitivity of noninvasive model for diagnosis of intrahepatic cholangiocarcinoma. through study completion, up to 2 years
Primary specificity Specificity of noninvasive model for diagnosis of intrahepatic cholangiocarcinoma. through study completion, up to 2 years
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