NCT07042308

Brief Summary

This is a retrospective-prospective registry cohort study. Patients with advanced chronic liver disease (ACLD) will be prospectively invited to this study. The study follow-up duration will be 10 years. The primary outcome is incident hepatic events and liver-related mortality. Participants will undergo annual transient elastography examination.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
116mo left

Started Sep 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Sep 2024Dec 2035

Study Start

First participant enrolled

September 25, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 29, 2025

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2035

Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

11.2 years

First QC Date

June 17, 2025

Last Update Submit

June 25, 2025

Conditions

CirrhosisAdvanced Chronic Liver Disease

Keywords

advanced chronic liver disease

Outcome Measures

Primary Outcomes (1)

  • Incident hepatic events and liver-related mortality

    Incident hepatic events (including ascites, variceal bleeding and overt hepatic encephalopathy) and liver-related mortality

    10 years

Secondary Outcomes (5)

  • Incidence rate of each hepatic event

    10 years

  • Incidence rate of hepatocellular carcinoma

    10 years

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

    10 years

  • Change in liver and spleen stiffness

    10 years

  • Exploratory outcome on identification of novel biomarkers

    10 years

Study Arms (1)

Patients with advanced chronic liver disease

Adult patients with advanced chronic liver disease

Diagnostic Test: Transient elastography

Interventions

Transient elastographyDIAGNOSTIC_TEST

Liver stiffness and spleen stiffness from transient elastography

Patients with advanced chronic liver disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The prospective cohort will comprise of consecutive patients with advanced chronic liver disease attending hepatology clinics or in-patient care in Prince of Wales Hospital in Hong Kong. All patients will be screened if the eligibility criteria are fulfilled.

You may qualify if:

  • Aged 18 or above
  • Known ACLD, defined by:
  • LSM \> 10kPa or
  • Clinical cirrhosis, suggested by 1. ultrasonography of the hepatobiliary system shows features of cirrhosis (e.g. shrunken and nodular liver) and portal hypertension (e.g. dilated portal vein, portal-systemic collaterals or varices, splenomegaly, ascites). 2. Oesophagogastroduodenoscopy (OGD) shows presence of oesophageal varices (OV) and/or gastric varices (GV) and/or portal hypertensive gastropathy.

You may not qualify if:

  • Current or past history of hepatocellular carcinoma (HCC)
  • History of liver transplantation
  • Asplenism or history of splenectomy
  • Serious medical illness with limited life expectancy of less than 6 months
  • Pregnancy
  • Unable to obtain or refusal of informed consent from patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 exploration or novel biomarkers, future genetic and biochemical research

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jimmy CT Lai, MB ChB

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jimmy CT Lai, MB ChB

CONTACT

85235054205jimmyctlai@cuhk.edu.hk

Angel Chim, MSc

CONTACT

85235054205angelchim@cuhk.edu.hk

Study Design

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

Study Record Dates

First Submitted

June 17, 2025

First Posted

June 29, 2025

Study Start

September 25, 2024

Primary Completion (Estimated)

December 1, 2035

Study Completion (Estimated)

December 1, 2035

Last Updated

June 29, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

Data may be shared upon reasonable request.

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)