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

NCT05327907 | Unknown DMC

• 1 other identifier: 202135719-Qilu
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrahepatic Cholangiocarcinoma

Keywords

Intrahepatic cholangiocarcinoma; Hepatocellular carcinoma; radiomics; nomogram

Outcome Measures

Primary Outcomes (3)

• 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

• sensitivity

  Sensitivity of noninvasive model for diagnosis of intrahepatic cholangiocarcinoma.

  through study completion, up to 2 years

• specificity

  Specificity of noninvasive model for diagnosis of intrahepatic cholangiocarcinoma.

  through study completion, up to 2 years

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• patients with pathological confirmation of ICC or HCC,
• CT was performed less than 15 days before surgery,
• Patients with complete clinical data.

You may not qualify if:

• history of other tumors,
• Metastatic liver cancer,
• Patients received preoperative chemotherapy or radiotherapy,
• Image quality analysis is not ideal.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• Jinan Central Hospital: collaborator
• Shandong Provincial Hospital: collaborator
• Jinan Military General Hospital: collaborator

Study Sites (1)

Department of Gastroenterology,Qilu Hospital,Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Yanjing Gao, PhD.MD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanjing Gao, PhD.MD

CONTACT

86-18560086087; gaoyanjing@sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 14, 2022
• Study Start: November 22, 2020
• Primary Completion: February 22, 2023
• Study Completion: May 22, 2023
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

CN (1)