Non-invasive Assessment for Outcome Prediction in Patients With Hepatocellular Carcinoma

NCT07036874 | Recruiting

• 1 other identifier: 2024.249
• Study Type: observational
• Target: 159
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-centre, prospective cohort study. Consecutive patients with compensated liver disease and hepatocellular carcinoma (HCC) for curative-intent treatment will be invited to this study. The study follow-up duration will be five years. The primary outcome is the composite of incident high-risk varices, hepatic decompensation and liver-related mortality. The participants will undergo transient elastography at baseline and then half-yearly post-HCC curative treatment; and oesophagogastroduodenoscopy (OGD) at baseline and then at year 1, 3 and 5 post-HCC curative treatment. Clinical assessments and laboratory tests will also be done at baseline and every 6 months until year 5 to identify any clinical events.

Conditions

HCC - Hepatocellular Carcinoma; Cirrhosis

Keywords

hepatocellular carcinoma; liver stiffness; spleen stiffness

Outcome Measures

Primary Outcomes (1)

• Composite of incident high-risk varices, hepatic decompensation and liver-related mortality

  Composite of incident high-risk varices, hepatic decompensation and liver-related mortality

  5 years

Secondary Outcomes (4)

• Development of each hepatic decompensation event

  5 years

• Recurrence of hepatocellular carcinoma

  5 years

• Changes in Child-Pugh and Model for End-stage Liver Disease scores

  5 years

• Change in liver and spleen stiffness measurements

  5 years

Study Arms (1)

Patients with hepatocellular carcinoma

Adult patients with known chronic liver disease and hepatocellular carcinoma planning for curative-intent treatment

Diagnostic Test: transient elastography and oesophagogastroduodenoscopy

Interventions

transient elastography and oesophagogastroduodenoscopy DIAGNOSTIC_TEST

Liver and spleen stiffness will be measured by transient elastography. Varices will be identified by oesophagogastroduodenoscopy.

Patients with hepatocellular carcinoma

Eligibility Criteria

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

Study Population

Consecutive adult patients with hepatocellular carcinoma fulfilling the inclusion and exclusion criteria will be invited to join the study.

You may qualify if:

• Aged 18 or above
• Known chronic liver disease(s)
• HCC for curative-intent treatment (defined by HCC diagnosed with typical radiological features or histology, and planned for surgical resection or local ablative therapy as a curative-intent treatment)

You may not qualify if:

• Current or history of decompensated liver cirrhosis (i.e. Child's C cirrhosis, prior decompensating events such as ascites, variceal bleeding, hepatic encephalopathy and hepatorenal syndrome)
• o Child's B cirrhosis without decompensating events is not excluded
• Past history of HCC (ie. The current HCC is a recurrence of priorly treated HCC or a second de novo HCC after previous first HCC)
• Non-primary liver tumour (such as secondary liver tumour due to metastasis from another distant primary tumour)
• History of liver transplantation or plan for liver transplantation as the modality of curative-intent HCC treatment
• Asplenism or history of splenectomy
• Contraindication to OGD (eg. Intestinal perforation of obstruction)
• Serious medical illness with limited life expectancy of less than 6 months
• Pregnancy
• Unable to obtain or refusal of informed consent from patient

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Store 10 mL of clotted blood and 10 mL of EDTA blood for future genetic and biochemical research

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Fibrosis

Interventions

Endoscopy, Digestive System

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; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Jimmy CT Lai, MB ChB

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jimmy CT Lai, MB ChB

CONTACT

85235054205; jimmyctlai@cuhk.edu.hk

Angel Chim, MSc

CONTACT

angelchim@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor (Clinical)

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 25, 2025
• Study Start: November 4, 2024
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 6 months after the first publication until 15 years after the end of the study
• Access Criteria: By email communication

Locations

HK (1)