Ignite Creation Date:
2024-05-06 @ 3:33 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04666402
Status:
RECRUITING
Last Update Posted:
2024-03-27
First Post:
2020-10-21
Brief Title:
Integrated Diagnostics for Early Diagnosis of Liver Disease
Sponsor:
Manchester University NHS Foundation Trust
Organization:
Manchester University NHS Foundation Trust
Study Overview
Official Title:
Integrated Diagnostics for Early Diagnosis of Liver Disease
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ID LIVER
Brief Summary:
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
Detailed Description:
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 UKs 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None