naVIGation Invitations Liver surveillANce upTake

Recruiting

• Conditions: Hepatocellular Carcinoma; Liver Cirrhosis; Chronic Hep B

• Registration Number: NCT06635694
• Lead Sponsor: Imperial College London

Brief Summary

This study aims to evaluate the efficacy of Patient Navigators and mailed surveillance invitations on attendance of Hepatocellular Carcinoma (HCC) ultrasound surveillance appointments. The investigators hypothesise that mailed invitations and Patient Navigators will improve attendance at HCC surveillance appointments and increase the proportion of patients diagnosed at an early stage, compared with a control group receiving usual care.

Detailed Description

Hepatocellular carcinoma (HCC) is the third leading cause of cancer-related death worldwide. Despite advances in treatment options, prognosis remains worrying, with 5-year survival rates remaining less than 20%.

Surveillance for HCC involves six-monthly ultrasounds (US) of the liver and has been demonstrated to increase rate of early diagnosis, which translates to improved survival. However, the uptake of HCC surveillance is low internationally; in Western countries, only 20% of patients eligible for HCC surveillance receive a surveillance test.

The current provision of HCC surveillance in the UK is ad hoc: eligible patients have six-monthly ultrasound requested by their clinician (usually a gastroenterologist, hepatologist or hepatology clinical nurse specialist). Patients receive an ultrasound appointment in the post with no formal invitation or information about the surveillance test. Work with focus groups suggests lack of knowledge and fear are barriers to HCC surveillance attendance.

Previous research has shown that patient navigation increased HCC surveillance uptake in an American population. However, there has been no research on interventions aimed at improving surveillance uptake in the UK population.

The study predicts that the mailed invitations and Patient Navigators will improve patient attendance at HCC surveillance and increases the number of patients diagnosed with early-stage HCC, compared with usual care.

Study Timeline

• Study First Submitted: 2024-10-08
• Study First Submitted QC: 2024-10-08
• Study First Posted: 2024-10-10
• Study Start: 2025-02-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-02
• Primary Completion: 2025-08-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 652

Inclusion Criteria

• 18 years of age or older
• ECOG performance status of 0-2
• Eligible for HCC surveillance as defined by NICE and EASL criteria
• Child Pugh A or B cirrhosis
• Child Pugh C cirrhosis AND on liver transplant waiting list
• High risk chronic hepatitis B

Exclusion Criteria

• Previous or current diagnosis of HCC
• Child Pugh C cirrhosis
• Frailty (Clinical Frailty Scale >7)
• Previous liver transplant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients in each arm attending HCC surveillance regularly	2 years
Attendance rates at 6-months intervals	2 years

Secondary Outcome Measures

Name	Time	Method
Proportion of patients in each arm diagnosed with HCC compared with late-stage HCC	2 years
Cost of intervention compared to standard of care	2 years

Trial Locations

Locations (1)

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom