Improving early diagnosis of liver disease using integrated diagnostics
Integrated Diagnostics for Early Diagnosis of Liver Disease
This study is trying to improve how quickly and accurately liver disease is diagnosed by combining different tests and information from around 750 patients who are at risk or have abnormal liver blood tests.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Manchester University NHS Foundation Trust Government |
| Locations | 1 site (Manchester, Greater Manchester) |
| Trial ID | NCT04666402 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enhance the early diagnosis of liver disease by integrating data from patients with liver conditions, novel blood biomarkers, single nucleotide polymorphism (SNP) analysis, and fecal microbiome analysis. The study will assess patients referred to Community Liver Assessment Clinics (CLAC) to create a comprehensive database that combines various diagnostic tools. By implementing this new assessment pathway, the investigators expect to reduce the number of patients needing secondary care while improving the identification of liver fibrosis. The study will involve approximately 750 patients annually, focusing on those with abnormal liver blood tests or at high risk for liver disease.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have been referred to a Community Liver Assessment Clinic.
Not a fit: Patients under 18 years old, those with known pre-existing liver disease, or those who are acutely unwell may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier and more accurate diagnosis of liver disease, allowing for timely intervention and better patient outcomes.
How similar studies have performed: Other studies have shown promise in using integrated diagnostic approaches for liver disease, but this specific methodology is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients referred to Community Liver Assessment Clinic. * Male or female \> 18 years of age. * Females will be non-pregnant and non-lactating. Exclusion Criteria: * Age \< 18 years. * Pregnancy/breast-feeding. Women of childbearing potential (not \>2 years post- menopausal and/or not surgically sterilised) must have a negative blood serum pregnancy test. * Isolated bilirubinaemia. * Known pre-existing liver disease. * Acutely unwell. * Suspected malignancy.
Where this trial is running
Manchester, Greater Manchester
- Manchester University NHS Foundation Trust — Manchester, Greater Manchester, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Varinder Athwal — Manchester University NHS Foundation Trust/Manchester University
- Study coordinator: Varinder Athwal
- Email: Varinder.athwal@manchester.ac.uk
- Phone: 0161 291 5354
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.