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.
The PBC Genetics Study
This is a UK-wide multicentre effort to establish a UK PBC Bioresource consisting of minimum 5000 unique PBC DNA samples, detailed phenotype information about each participant, and the facility to recall selected participants to provide blood and other samples for immunophenotyping and related studies. Samples from the UK PBC Bioresource were recently utilised in a highly successful genome-wide association study (GWAS) of PBC, which has identified several previously unreported risk loci for PBC. Ongoing recruitment is required to suitably power future studies to identify genetic loci which influence disease progression or confer risk of important sub-phenotypes, including pruritus and fatigue.
Almost all NHS Trusts in the UK are involved in this study and approximately 3500 PBC cases have been enrolled in the study. It is feasible to recruit a total of 5000 cases within 12 months, if clinicians remain enthusiastic. Please continue to support this project.
A UK Collaberative Study to Determine the Genetic Basis of Primary Sclerosing Cholangitis (UK-PSC).
This is an observational case-control genome wide association study. The primary aim of the study is to determine the genetic factors predisposing and contributing to the development of PSC. The secondary objective is to determine the molecular mechanisms by which genetic variants associated with PSC cause disease. Also from the patient and clinician questionnaire epidemiological information will be collected, which would provide us with phenotypic characteristics of the largest cohort of PSC patients in the British population.
To date, 1400 patients have been recruited from over 120 NHS trusts and 1050 DNA samples have been collected, expecting to reach 1500 samples by December. Current recruitment is 40 new patients each month. There has been tremendous support from the UK CLRN research nurses who have helped with patient recruitment in the participating trusts. Approval awaited from a further 15 trusts in the UK including Northern Ireland. Please contact trial team if you need any further information regarding the study or recruitment process.
Dr Brijesh Srivastava
Clinical Research Fellow Addenbrooke’s Hospital, Cambridge.
Phone: 01223 769 088
Dr Simon Rushbrook
Chief Investigator Consultant Hepatologist
Norfolk & Norwich University Hospital, Norwich.
Proteomic and metabonomic profiling for biomarkers in benign and malignant hepatic and pancreatobiliary disease.
This study will utilise proteomic, genomic and metabonomic techniques in the discovery of novel biomarkers of hepatocellular carcinoma (HCC) and pancreaticobiliary diseases including cholangiocarcinoma (CC), pancreatic cancer and benign biliary disease. For malignant cases, diagnosis based upon cytology or histology is considered confirmed. However, a positive combination of clinical course, multi-modal imaging, serum markers and HPB cancer MDT consensus is also considered adequate confirmation of diagnosis for this study. Procedures: blood sample and urine sample, and short demographic, medical and dietary questionnaire. Collaborating centres with substantial HCC and CC caseloads are initially sought. Collaborating centres should have the facility to complete simple sample processing (centrifugation, aliquoting of supernatant) and store samples at -80oC pending transfer to the hub centre. This study has been adopted by the UKCRN and a per case payment can be accrued by participating centres.
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