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NCT Number: NCT07479264

A Study on Intratumoral Fibrosis and α-SMA Expression in Intrahepatic Cholangiocarcinoma

The aim of this observational study was to understand the prognostic imaging of the degree of intratumoral fibrosis and intratumoral α-SMA levels in patients with intrahepatic cholangiocarcinoma (ICC). The main questions it aims to answer are:

Whether the degree of intratumoral fibrosis and the level of intratumoral α-SMA affect the overall survival and progression-free survival of ICC patients.

Participants will be surveyed for survival and tumor recurrence up to 5 years after surgery.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

About this study

Intrahepatic cholangiocarcinoma (ICC), which originates from the proximal secondary bile duct in the liver parenchyma (based on the direction of bile flow), is the second most common type of primary liver cancer after hepatocellular carcinoma, accounting for 10-20% of all primary liver cancers. In recent years, the incidence and mortality of ICC have been increasing in most regions of the world. α-SMA-positive CAFs in ICC may aggravate tumor progression and reduce survival time, which is a significant prognostic indicator. However, the evaluation of α-SMA expression level in previous studies mostly relied on subjective evaluation by pathologists after visual observation, and there was a lack of quantitative indicators. In addition, there are differences in the effect of intratumoral fibrosis on the prognosis of ICC, and there may be an interactive relationship between the expression of α-SMA and intratumoral fibrosis. The effect of intratumoral α-SMA expression level and fibrosis on the prognosis of ICC still deserves further exploration. Therefore, the aim of this study is to investigate the relationship between the expression level of α-SMA and the degree of fibrosis in ICC and Progression-free survival (PFS) and Overall survival (OS) by survival analysis. To determine the expression level of α-SMA and the risk degree of fibrosis in ICC.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who underwent radical resection of liver tumors in our center and obtained surgical specimens;
  • ICC was diagnosed by postoperative pathology

Exclusion criteria

  • Patients had received radiotherapy, chemotherapy, intervention and other treatments for liver tumors before surgery
  • The tumor sections could not be obtained due to the loss of wax blocks or most of the defects of pathological specimens
  • No upper abdominal Gd-EOB-DTPA-enhanced MRI examination in our center within one month before surgery
  • Poor image quality or incomplete image data

Treatment and study plan

No interventions

Other

Only the degree of intratumoral fibrosis and the expression of α-SMA in the postoperative pathological specimens of ICC patients were observed, without intervention measures.

Primary outcomes

  1. Treatment Effects

    Time frame: From the time of the patient's surgery to the end of the 5-year follow-up

    5-year overall survival (OS)

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study title

MRI-Based Radiomics and Machine Learning for Preoperative Assessment of Intratumoral Fibrosis and α-Smooth Muscle Actin Expression in Intrahepatic Cholangiocarcinoma

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Mar 18, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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