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Workstream 3


This is the clinical trial work stream. The main focus of workstream 3 is to evaluate the impact of three new biomarkers for liver damage - together called the ‘Enhanced Liver Fibrosis’ or ELF test. 

Workstream 3 performs a multicentre randomised clinical trial called ELUCIDATE. The aim of this trial is to determine whether ELF can give early warning of dangerous liver damage (cirrhosis) and therefore reduce the risk of major complications. This trial has the potential to radically alter the way in which patients with liver disease can be looked after. 

The flow diagram below outlines the patient pathway through the trial.

ELUCIDATE Flow Diagram

*Registration line due to close 28/02/2013

**Randomisation line due to close 30/04/2013

Recruitment

Recruitment for ELUCIDATE was slightly delayed in the initial few months due to unexpected delays in trial set up. However, recruitment progressively increased with February 2013 being a record month for registrations. Following closure of recruitment in April 2013, we can report that a total of 37 sites were open, leading to 878 patients randomised - only 122 short of the planned 1000, which will provide a satisfactory 85% power for the primary outcome analysis. The graph below illustrates the final accrual figures for the ELUCIDATE trial.

ELUCIDATE Accrual to December 2013

Next Steps

Following closure of registration and randomisation, the next steps for workstream 3 are as follows:

  • randomised patients will now be followed-up until July 2014
  • semi-structured interviews with 10-12 trial participants and carers will take place early 2014 in order to inform future research
  • the analysis and reporting of the ELUCIDATE trial in January 2015.
Reporting

We will report on the following by January 2015:

  • review of the trial
  • impact on diagnosis
  • impact of the ELF Test on the process of care 
  • a number of process-related outcomes including numbers treated with beta-blockers/band ligation, and numbers being given scans such as ultrasound/OGD.




This website presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (RP-PG-0707-10101: Evaluating the benefits for patients and the NHS of new and existing biological fluid biomarkers in liver and renal disease)

The views and opinions expressed by the authors of this website are those of the authors and do not necessarily reflect those of the NHS, the NIHR or the Department of Health.

 
The Leeds Teaching Hospital NHS Trust 2014