Idiosyncratic Drug-induced Liver Injury Study (DILIGEN)
The international Drug-induced Liver Injury Consortium (iDILIC), is studying the genetic susceptibility to idiosyncratic drug-induced liver injury. The UK arm of the study is DILIGEN. The study, involves collecting DNA from cases and suitable controls for a genome wide association study (GWAS) with the aim of identifying polymorphisms predictive of the development of drug-related liver injury and hence allowing the possibility of prevention. We will be grateful to physicians treating idiosyncratic drug-induced liver injury cases, particularly BSG members, to put us in contact with suitable patients.
Patients who developed one of the following due to drug-induced liver injury are suitable to be included:
Histological AssessmeNt Determining EpitheliaL Response.
Chief investigator: Professor Janusz Jankowski
Sponsor: Queen Mary, University of London
Design: Observational/Interventional study collecting blood and tissue samples from patients recruited into Cancer Oesophagus Gefitinib-COG Study and blood samples from patient's family members with history of severe oesophagitis, Barrett's oesophagus and/or oesophageal cancer for genetic and molecular biological studies.
Planned /actual start date: 15/01/2010
Planned close date: 21/03/2014
Target number of patients: 1000
Number of patients recruited: Recruiting
Number of centres needed: 35
Number of centres recruiting: 1
(Manoj Nanji, Trial manager)
STOPAH (Steroids or Pentoxifylline in Alcoholic Hepatitis) is a multicentre UK trial funded by NIHR-HTA. This is a vital study in UK hepatology looking to prove the role of steroids or pentoxifylline versus placebo in the treatment of a condition which is increasingly common in the UK. Patients with DF>32 are eligible and the study is designed to be pragmatic with few exclusions to treatment. Primary outcome is 30 day mortality but with follow-up to a year.
Update: March 2011
This has been delayed partly due to issues regarding trial drug provision. A hub-and-spoke distribution provides the most cost-efficient method of provision, but has caused some logistical difficulties at a local level. However, these are starting to be resolved and the first patients are now being recruited. Please contact the CI or trial coordinator if you are interested in taking part. .
BOSS (Barrett's Oesophagus Surveillance Study)
BOSS. Barrett’s Oesophagus Surveillance Study. Endoscopic surveillance vs no endoscopic surveillance for the prevention of early mortality in patients diagnosed with Barrett’s oesophagus. Patients randomized to receive endoscopy with biopsy every two years for 10 years or endoscopy at the time of need. All patients receive a bi-annual postal questionnaire to record their symptoms and other health related data (administered by the centre). Patients followed up for 10 years. Sample size = 2500.
Update: March 2011
We have 109 hospitals opened to recruitment, we are more than happy to accept other hospitals if they wish to join us. We are currently in negotiations with the HTA to increase our numbers from 2,500 to 3,400.
Take home message: " BOSS is recruiting at a fast pace now thank s to all our colleagues across the UK, please keep this up".
Any patients recruited to BOSS should also be considered for ChOPIN.
The ChOPIN/IPOD study aims to assess both epigenetic and genetic changes which lead to pre-malignancy and ultimately to cancer. The study has two interrelated parts: 1) Chopin biomarkers, array and assessment of clonal changes early in cancer; 2) Chopin/IPOD genome wide study (inherited predisposition of oesophageal diseases) – IPOD. The biomarker study will be conducted in patients who have undergone cancer resection operations and are being followed up by the clinical teams who will have clinical and pathological records. The IPOD study will aim to collect blood samples from patients with Barrett’s oesophagus for DNA analysis. This study is suitable for all patients recruited to BOSS.
The aims are to identify genes that predispose to Barrett’s and, through this work, to identify oesophageal cancer predisposition genes.
Update: March 2011
The trial is recruiting well with 52 sites active to date and others in the process of site approval. A total of 70 sites are required so these is still opportunity for pthers to show interest. Recruitment is ahead of schedule and the target of 3000 is looking very achievable.
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