Hepatocellular CarcinomaVIGILANTNCT06635694
naVIGation Invitations Liver surveillANce upTake
An observational study of Hepatocellular Carcinoma and Liver Cirrhosis, run by Imperial College London at 1 site in United Kingdom.
Trial summary
This study aims to evaluate the efficacy of Patient Navigators and mailed surveillance invitations on attendance of Hepatocellular Carcinoma (HCC) ultrasound surveillance appointments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Cirrhosis, Chronic Hep B
- How many people
- 652 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Feb 2025to 19 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving 6-monthly ultrasound surveillance for HCC
Who may be able to join
- 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
Who cannot join
- Previous or current diagnosis of HCC
- Child Pugh C cirrhosis
- Frailty (Clinical Frailty Scale >7)
- Previous liver transplant
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College Healthcare NHS Trust
London, W12 0HS
About this study
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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma, Liver Cirrhosis, Chronic Hep B
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Cirrhosis, Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Responsible clinician will request surveillance imaging and ultrasound appointment will be booked using an automated call/recall system. A formal invitation to surveillance and an informational sheet will be sent by post to patient's home address, addressing concerns including fear, and FAQs e.g. duration of scan and level of discomfort. Patients will receive a reminder 2 weeks prior to their appointment. Results will be automatically sent to the relevant hepatology unit and GP. Patients will be informed of results by mail or through "patientknowsbest" app, and invited for repeat ultrasound in 6 months. Patients with abnormal results will be contacted by the direct care team to organise further investigations. Non-attendance will be followed by a further appointment letter/text. Patients who fail to attend 2 appointments will be contacted by the direct care team. Their reasons for non-attendance will be recorded and GP contacted. | |
| Patient Navigator | Patients will receive usual care plus a scripted phone call from a Patient Navigator the week prior to the surveillance appointment to remind patients, offer to reschedule the appointment if the patient is unable to attend, and address any concerns about the appointment. All other procedures will be the same as usual care. Additionally, Navigators will call patients who have not attended surveillance imaging appointments to explore any barriers to attendance and how these might be addressed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance rates at 6-months intervals
Measured: 2 years
Proportion of patients in each arm attending HCC surveillance regularly
Measured: 2 years
Secondary outcomes (2)
Proportion of patients in each arm diagnosed with HCC compared with late-stage HCC
Measured: 2 years
Cost of intervention compared to standard of care
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start27 Feb 2025
- Primary completion19 Aug 2027 (estimated)
- Study completion19 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 652 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- RM Partners
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635694
- Sponsor's protocol ID
- 23HH8630
- Acronym
- VIGILANT
- Status last verified
- Jan 2026
- First submitted
- 8 Oct 2024
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pandiaraja M, Qurashi M, Izadi H, Martinez M, Sharma R. Efficacy of mailed surveillance invitations and telephone patient navigation to improve hepatocellular carcinoma surveillance uptake: study protocol of VIGILANT-a single-centre, two-arm randomised controlled trial. BMJ Open. 2025 Jun 30;15(6):e097162. doi: 10.1136/bmjopen-2024-097162.
PubMed 40588390
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- naVIGation Invitations Liver surveillANce upTake
- ClinicalTrials.gov ID
- NCT06635694
- Acronym / sponsor ID
- VIGILANT / 23HH8630
- Conditions
- Hepatocellular Carcinoma, Liver Cirrhosis, Chronic Hep B
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 652 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- RM Partners
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 19 Aug 2027 (estimated)
- Study completion
- 19 Aug 2027 (estimated)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | – | –Responsible clinician will request surveillance imaging and ultrasound appointment will be booked using an automated call/recall system. A formal invitation to surveillance and an informational sheet will be sent by post to patient's home address, addressing concerns including fear, and FAQs e.g. duration of scan and level of discomfort. Patients will receive a reminder 2 weeks prior to their appointment. Results will be automatically sent to the relevant hepatology unit and GP. Patients will be informed of results by mail or through "patientknowsbest" app, and invited for repeat ultrasound in 6 months. Patients with abnormal results will be contacted by the direct care team to organise further investigations. Non-attendance will be followed by a further appointment letter/text. Patients who fail to attend 2 appointments will be contacted by the direct care team. Their reasons for non-attendance will be recorded and GP contacted. |
| Patient Navigator | – | –Patients will receive usual care plus a scripted phone call from a Patient Navigator the week prior to the surveillance appointment to remind patients, offer to reschedule the appointment if the patient is unable to attend, and address any concerns about the appointment. All other procedures will be the same as usual care. Additionally, Navigators will call patients who have not attended surveillance imaging appointments to explore any barriers to attendance and how these might be addressed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving 6-monthly ultrasound surveillance for HCC
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Previous or current diagnosis of HCC
- Child Pugh C cirrhosis
- Frailty (Clinical Frailty Scale >7)
- Previous liver transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Attendance rates at 6-months intervals
Time frame: 2 years
Proportion of patients in each arm attending HCC surveillance regularly
Time frame: 2 years
2 secondary outcomes
Proportion of patients in each arm diagnosed with HCC compared with late-stage HCC
Time frame: 2 years
Cost of intervention compared to standard of care
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Derived from this study: PubMed 40588390Pandiaraja M, Qurashi M, Izadi H, Martinez M, Sharma R. Efficacy of mailed surveillance invitations and telephone patient navigation to improve hepatocellular carcinoma surveillance uptake: study protocol of VIGILANT-a single-centre, two-arm randomised controlled trial. BMJ Open. 2025 Jun 30;15(6):e097162. doi: 10.1136/bmjopen-2024-097162.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Liver Cirrhosis, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance rates at 6-months intervals (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06635694, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.