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Establishment of Scoring Model for Early and Differential Diagnosis of Intrahepatic Cholangiocarcinoma

Sponsor
Qilu Hospital of Shandong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05327907
Collaborator
Jinan Central Hospital (Other), Shandong Provincial Hospital (Other), Jinan Military General Hospital (Other)
300
Enrollment
1
Location
29.9
Anticipated Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Establishment of Scoring Model for Early Diagnosis and Differential Diagnosis of Intrahepatic Cholangiocarcinoma
    Actual Study Start Date :
    Nov 22, 2020
    Anticipated Primary Completion Date :
    Feb 22, 2023
    Anticipated Study Completion Date :
    May 22, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Training cohort

    Training cohort consists of the patients diagnosed with intrahepatic cholangiocarcinoma who collected from January 2010 to July 2021 retrospectively.
    Internal validation cohort

    Internal validation cohort consists of the intrahepatic cholangiocarcinoma patients who enrolled from September 2021 of Qilu Hospital prospectively.
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Accuracy [through study completion, up to 2 years]

      The golden standard is the pathological biopsy.Compare the accuracy of the noninvasive model with the pathological biopsy.

    2. sensitivity [through study completion, up to 2 years]

      Sensitivity of noninvasive model for diagnosis of intrahepatic cholangiocarcinoma.

    3. specificity [through study completion, up to 2 years]

      Specificity of noninvasive model for diagnosis of intrahepatic cholangiocarcinoma.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Gastroenterology,Qilu Hospital,Shandong University Jinan Shandong China 250012

    Sponsors and Collaborators

    • Qilu Hospital of Shandong University
    • Jinan Central Hospital
    • Shandong Provincial Hospital
    • Jinan Military General Hospital

    Investigators

    • Principal Investigator: Yanjing Gao, PhD.MD, Qilu Hospital, Shandong University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yanjing Gao, Clinical Professor, Qilu Hospital of Shandong University
    ClinicalTrials.gov Identifier:
    NCT05327907
    Other Study ID Numbers:
    • 202135719-Qilu
    First Posted:
    Apr 14, 2022
    Last Update Posted:
    Apr 14, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yanjing Gao, Clinical Professor, Qilu Hospital of Shandong University
    Intrahepatic cholangiocarcinoma
    Hepatocellular carcinoma
    radiomics
    nomogram
    Additional relevant MeSH terms:
    Cholangiocarcinoma

    Study Results

    No Results Posted as of Apr 14, 2022