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OpenTrials
Active, Not Recruiting

NCT Number: NCT06635694

naVIGation Invitations Liver surveillANce upTake

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Attendance rates at 6-months intervals

    Time frame: 2 years

  2. Proportion of patients in each arm attending HCC surveillance regularly

    Time frame: 2 years

Secondary outcomes

  1. Proportion of patients in each arm diagnosed with HCC compared with late-stage HCC

    Time frame: 2 years

  2. Cost of intervention compared to standard of care

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • RM Partners

Registry information

Acronym: VIGILANT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 10, 2024
Registry last updated
Jan 14, 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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