An observational study in Intrahepatic Cholangiocarcinoma, sponsored by Qilu Hospital of Shandong University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-04-14.
Sponsored by Qilu Hospital of Shandong University · Observational
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.
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.
914 studies on the registry are indexed under Cholangiocarcinoma; 286 are open to participants now.
This study's planned enrollment of 300 is above the median of 196 across 176 observational studies indexed under Cholangiocarcinoma.
Browse Cholangiocarcinoma studies →Qilu Hospital of Shandong University is the lead sponsor of 299 studies on the registry; 181 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Training cohort consists of the patients diagnosed with intrahepatic cholangiocarcinoma who collected from January 2010 to July 2021 retrospectively.
Internal validation cohort consists of the intrahepatic cholangiocarcinoma patients who enrolled from September 2021 of Qilu Hospital prospectively.
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.
Accuracy
The golden standard is the pathological biopsy.Compare the accuracy of the noninvasive model with the pathological biopsy.
Time frame: through study completion, up to 2 years
sensitivity
Sensitivity of noninvasive model for diagnosis of intrahepatic cholangiocarcinoma.
Time frame: through study completion, up to 2 years
specificity
Specificity of noninvasive model for diagnosis of intrahepatic cholangiocarcinoma.
Time frame: through study completion, up to 2 years
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Qilu Hospital of Shandong University