Condition category
Digestive System
Date applied
06/08/2009
Date assigned
11/11/2009
Last edited
18/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof William Rosenberg

ORCID ID

Contact details

Windeyer Institute of Medical Sciences
46 Cleveland Street
London
W1T 4JF
United Kingdom
+44 20 7794 0500
w.rosenburg@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RP-PG-0707-10101

Study information

Scientific title

Evaluating the benefits for patients and the UK National Health Service (NHS) of new and existing biological fluid markers in liver and renal disease: a prospective multicentre randomised trial

Acronym

ELUCIDATE

Study hypothesis

The primary aim of the study is to evaluate the benefits to patients and the NHS of new and existing biological fluid markers in liver and renal disease, which aims to develop a stringent approach to protein biomarker evaluation. This trial will determine whether the use of the enhanced liver fibrosis (ELF) test will significantly alter the diagnostic timing and subsequent management of cirrhosis of the liver in order to reduce serious complications and improve outcomes for patients and service provision.

Ethics approval

Not provided at time of registration

Study design

Prospective multicentre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic liver disease

Intervention

Patients will be randomised to either:
1. ELF arm: patients in the ELF arm will undergo follow-up screening for cirrhosis with the ELF test
2. Standard care arm: patients in the standard care arm will undergo standard follow-up screening for cirrhosis

Patients will be followed up at 6 monthly intervals until 30 months after randomisation.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Time from clinical diagnosis of cirrhosis to incidence of any of the following severe complications:
1. Variceal haemorrhage
2. Mortality due to variceal haemorrhage
3. Spontaneous bacterial peritonitis
4. Mortality due to hepatocellular cancer (HCC)

Patients will undergo follow-up visits at 6-monthly intervals, increasing to 3-monthly intervals after diagnosis of cirrhosis, for 30 months post-randomisation. Outcome data will be collected at each visit.

Secondary outcome measures

1. Time from randomisation to clinical diagnosis of cirrhosis (to allow instigation of prophylaxis and screening)
2. Detection and timing of complications following cirrhosis, including:
2.1. Detection of small varices
2.2. Detection of large varices
2.3. Incidence of treatable hepatocellular cancer (HCC)
2.4. Incidence of inoperable HCC
3. All causes of mortality
4. Economic evaluation of the ELF test in the early detection of cirrhosis and as such in the initiation of measures to reduce the incidence of severe complications following cirrhosis

Patients will undergo follow-up visits at 6-monthly intervals, increasing to 3-monthly intervals after diagnosis of cirrhosis, for 30 months post-randomisation. Outcome data will be collected at each visit.

Overall trial start date

01/09/2009

Overall trial end date

01/09/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Registration:
1. Patients with chronic liver disease and pre-cirrhotic moderate to severe fibrosis as classified by clinical, laboratory, or histological evidence, due to viral hepatitis B or C, non-alcoholic fatty liver disease, alcoholic liver disease, primary biliary cirrhosis (PBC), primary sclerosing cholangitis (PSC), autoimmune hepatitis (AIH), haemochromatosis, or combinations of these diseases
2. Clinical evidence of chronic liver disease as evidenced by documented abnormalities of liver function for more than six months including:
2.1. Elevated liver enzymes (alanine aminotransferase [ALT], asparate aminotransferase [AST], gamma glutamyl-transferase [GGT])
2.2. Elevated bilirubin with raised liver enzymes
2.3. Symptoms or signs of chronic liver disease (including jaundice, clubbing, palmar erythema, spider naevae)
3. Chronic liver disease due to:
3.1. Virus-serological and nucleic acid evidence of chronic Hepatitis C, chronic Hepatitis B
3.2. Fat: ultrasound evidence of fatty liver disease
3.3. Alcohol: history of excessive alcohol consumption
3.4. Autoimmune hepatitis (smooth muscle antibodies [SMA], anti-nucleur antibodies [ANA], liver-kidney-microsome antibodies [LKMA] and raised immunoglobins)
3.5. Primary biliary cirrhosis (anti-mitochondrial antibodies [AMA], M2 antibodies)
3.6. Primary sclerosing cholangitis (endoscopic retrograde cholangiopancreatography [ERCP] or magnetic resonance cholangiopancreatography [MRCP] evidence of beading of biliary tree)
3.7. Haemochromatosis-HFE genotype HDCY or HHYY with liver biopsy evidence of iron overload
4. Aged greater than or equal to 18 years old and less than 75 years of age, either sex
5. Give their written, informed consent to participate
6. Likelihood of ability to comply with the follow-up schedule
7. Life expectancy greater than 6 months

Randomisation:
8. An ELF score of greater than or equal to 10.5

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1000

Participant exclusion criteria

Registration:
1. Unable to provide consent
2. Clinical, histological or laboratory diagnosis of cirrhosis (other than ELF) such as hepatic impairment as evidenced by any one of the following:
2.1. Platelets less than the lower limit of normal (LLN)
2.2. Albumin less than LLN
2.3. Ultrasound of other imaging evidence of cirrhosis (coarse echo texture, irregular outline to liver, splenomegally)
OR
3. Any episode of hepatic decompensation compatible with cirrhosis including:
3.1. Encephalopathy, variceal bleeding, ascites
3.2. Established diagnosis of hepatocellular cancer
3.3. Elevated alpha feto-protein without investigation to exclude HCC
4. Previously screened and found ineligible for the ELUCIDATE Trial

Note that human immunodeficiency virus (HIV) co-infection is NOT an exclusion criterion.

Randomisation:
5. An ELF score of less than 10.5

Recruitment start date

01/09/2009

Recruitment end date

01/09/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Windeyer Institute of Medical Sciences
London
W1T 4JF
United Kingdom

Sponsor information

Organisation

University of Leeds (UK)

Sponsor details

Woodhouse Lane
Leeds
LS2 9JT
United Kingdom
+44 (0)113 243 1751
governance-ethics@leeds.ac.uk

Sponsor type

University/education

Website

http://www.leeds.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) (ref: RP-PG-0707-10101)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

18/11/2016: No publications found in PubMed, verifying study status with principal investigator.