Integrated Diagnostics for Early Diagnosis of Liver Disease

Обзор

This is an observational study that will explore the hypothesis that by combining data from patients with liver disease with novel blood biomarkers, single nucleotide polymorphism (SNP) analysis and faecal microbiome analysis. The Investigators will improve diagnosis of liver fibrosis compared to the current available diagnostic tools.

Подробное описание

Liver disease is a silent epidemic. Four in ten people in the North West are likely to have evidence of liver disease. A small but significant proportion of these patients develop scarring, leading to end-stage cirrhosis. All too frequently this is detected in very advanced stages, where treatment cannot reverse the condition. It is one of the UK's largest health challenges. At present clinicians use a wide range of single tests that individually struggle to identify disease and high-risk patients early.

The Investigators are implementing a new pathway for the assessment of patients with abnormal liver blood tests or high risk for liver disease. This novel pathway will allow assessment of patients in Community Liver Assessment Clinics (CLAC) with the expectation that only 20% of patients assessed would need to be seen in secondary care for further assessment. The investigators expect, to be assessing, 750 patients per year in this pathway. This pathway will bring together a large group of patients with liver disease. As part of the clinical assessment the investigators will be undertaking investigations to diagnose disease and assess extent. This will generate significant information, that the investigators currently use in isolation to make the aforementioned assessments. In this study, the investigators would like to bring together all this data into a curated database. To this end, the investigators would offer all patients who attend the CLAC for clinical need to enrol into the study. This would generate a database to combine all data, alongside some other, non-invasive tests, done alongside routine clinical tests.

This project will address this lack of answers by teaming up with innovative companies to make software that joins together a wide range of different tests to make an algorithm to detect disease earlier.

Вмешательства

• Другое Blood tests for Single Nucleotide Polymorphisms
  This extra test would be performed on participants assessed in the specialist liver clinic. This test would require an extra 5ml of blood to be taken at the time of routine blood tests for clinical purposes.
• Диагностический тест Faecal microbiome analysis
  This test will be undertaken for all participants who give consent and are assessed through the new liver care pathway, in the community liver assessment clinic. All participants will be given the equipment to take a stool sample at the time of presentation at the community liver assessment clinic and asked to return the sample to the clinic. The sample will be processed to remove genetic material so the microbiome can be identified.
• Диагностический тест Serum for diagnostic biomarkers
  Blood samples will be taken alongside blood taken for clinical assessment. In total, an extra 5ml of blood. These samples will be used to explore novel blood biomarkers using ELISA and mass-spectroscopy techniques in the University of Manchester.

Первичные конечные точки

• Reduction in patient numbers requiring secondary care appointments for the investigation of advanced liver fibrosis. [Срок оценки: At study completion; within 3 years]

Вторичные конечные точки (1)

• To define the metrics involved in the diagnosis of advanced liver fibrosis or cirrhosis [Срок оценки: At study completion; Within 3 years]

Критерии участия

Критерии включения

• All patients referred to Community Liver Assessment Clinic.
• Male or female > 18 years of age.
• Females will be non-pregnant and non-lactating.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Великобритания · 1 центр

• Manchester University NHS Foundation Trust — Manchester

Идентификаторы

NCT: NCT04666402 · B00907

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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