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Determining the optimum strategy for the detection of advanced liver disease in primary care interface

Stratification Of LIver Disease (SOLID): Determining the optimum biomarker strategies for the detection of advanced liver disease at the primary-secondary care interface

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN31148824
Enrollment
3000
Registered
2022-12-21
Start date
2022-10-31
Completion date
Unknown
Last updated
2024-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diseases of the liver Digestive System

Interventions

Patients attending for their ‘annual year of care review’, ‘chronic disease review’ or ‘health check’ in primary care will be invited to participate in this study if they have risk factors for liver d
Fibroscan) and a metabolic assessment. All participants will be given relevant lifestyle advice and an information booklet with advice on how to reduce their risk of liver disease progression. We wi

Sponsors

Newcastle upon Tyne Hospitals NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Individuals aged 18-80 years attending for an ‘annual review of care’, ‘chronic disease review’ or ‘health check’ with one or more of the following risk factors for liver disease: 1. Obesity (BMI > 30), 2. Type 2 diabetes 3. Potentially harmful alcohol consumption (AUDIT score > 8) We have included an upper cut-off for the age of 80 for inclusion in this study. This is because liver disease generally has a slow progression to liver-related complications even with compensated cirrhosis, and as a result, asymptomatic individuals > 80 years are unlikely to benefit from early detection of liver disease.

Exclusion criteria

Exclusion criteria: 1. Life limiting disease on high risk or palliative care register 2. Known liver disease under secondary care follow up 3. Refusal or inability (lack of capacity) to provide informed consent 4. Unable to understand or speak English

Design outcomes

Primary

MeasureTime frame
Number of patients identified with advanced liver fibrosis/cirrhosis using each of the pathways based on an overall clinical evaluation by a panel of hepatologists measured using study records at a single time point

Secondary

MeasureTime frame
1. Usefulness of non-invasive testing/triage strategies to identify patients who have liver-related events (death, hepatic decompensation, transplantation) during longitudinal follow-up at 2, 5 and 10 years measured using electronic care records/NHS Digital 2. Performance of FIB-4, ELF, PRO-C3 and other novel blood-based biomarkers alone or in combination measured using overall clinical assessment or LSM to identify advanced fibrosis/cirrhosis at a single timepoint 3. Performance of the biomarkers to correctly exclude advanced fibrosis/cirrhosis as defined by overall clinical assessment or LSM at a single timepoint 4. Development of the optimum pathway (clinically and cost-effective and implementable)

Countries

United Kingdom

Contacts

Public ContactLorna Brownlee
lorna.brownlee@nhs.net+44 (0)191 213 9040

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026