Update: March 2012
TOPPIC reached its target recruitment of 234 patients on 14 March 2012. It required a huge amount of work from staff across 34 hospitals to accomplish this and we are very proud to have reached this milestone, having been given the opportunity to prove we could complete the study when given an extension by the MRC. Professor Satsangi wishes to thank everyone for taking part in the largest study in post-operative Crohn's disease ever carried out.
Background: TOPPIC was a multicentre RCT of the efficacy of 6MP in the prevention of recurrence of Crohn’s Disease after ileo-colonic or small bowel resection. Patients were recruited within 3 months of surgery and received 6MP or placebo for up to 3 years (156 weeks) and attended 12 study visits during this time. As of March 2011, TOPPIC Recruitment stood at 142 randomised patients. As such, the study had overtaken previous studies in this field, and the investigators hoped to provide a definitive answer to the unresolved issue as to the role of thiopurines in prevention of post-operative recurrence in Crohn's disease. 2011 got off to a very strong start in terms of recruitment and all sites were thanked. A further 92 patients had to be recruited to reach the target of 234, with only 13 months left. There were 27 sites throughout the UK, with 4 more still seeking approval as of March 2011, and TOPPIC was closed to any further new sites. A series of roadshows was being undertaken to address recruitment issues.
HOT II Trial Update
Update on HOT II Trial – Last call for volunteers
Following a further extension of the accrual period for HOT II, 75% of the target sample has undergone the consent process. Treatment is delivered at participating hyperbaric medicine centres in Cardiff, Chichester, Great Yarmouth, Hull, London (Leytonstone and St John's Wood), Plymouth, Poole and Rugby. Assessments are carried out at the Royal Marsden Hospital in London, with the option of postal consent for patients unable to make more than one journey.
As there is a 3-month run-in period, accrual needs to finish at the end of March 2012 in order for all volunteers to be treated by the end of the year. Although there is a list of patients in work-up for the study, the trial is still looking for 5-10 additional volunteers who may be interested in taking part. The HOT II Trial Coordinator would therefore be grateful if you could let her know of any potentially suitable volunteers amongst your patients AS SOON AS POSSIBLE.
For further information or to refer a patient, please see below.
Thank you for your help.
HOT II Trial Coordinator
HOT II summary and contact details
HOT II is a randomised double-blind controlled phase III trial of hyperbaric oxygen in patients suffering long-term adverse effects of radiotherapy (RT) for pelvic cancer, funded by Cancer Research UK and the Department of Health (ISRCTN 86894066). It aims to test the efficacy of HBO in permanently reducing gastrointestinal symptoms caused by pelvic radiotherapy at least 12 months before and which persist despite optimal gastroenterological management.
If you have patients with chronic RT-induced symptoms in your clinic who fit the following main inclusion criteria:
- Past history of cancer of the rectum, prostate, testis, bladder, uterine cervix, uterine corpus or ovary
- Bowel symptoms due to RT: diarrhoea, faecal incontinence, bleeding etc
- Radiotherapy at least 12 months ago
Chief & Principal Investigators:
Dr Jervoise Andreyev, Consultant Gastroenterologist in Pelvic Radiation Disease
Prof John Yarnold, Consultant Clinical Oncologist
For further information, please see Royal Marsden HOT-II or contact Grace Sharp directly at the address below:
HOT II Trial Coordinator
Professor Yarnold's Office
Royal Marsden Hospital, Downs Road, Sutton, Surrey SM2 5PT
PRED4 - rare adverse events studies
The UK IBD Genetics Consortium has started recruitment for the PRED4 study, which is now open in a number of sites. The team is currently busy opening the rest of the sites in the UK (similar to the 5-ASA-induced nephrotoxicity study). These studies are investigating drug-related rare adverse events and aim to identify clinically useful genetic markers that predict serious drug side effects, in particular:
• Thiopurine-induced pancreatitis
• Thiopurine-induced leucopaenia
• Anti-TNF-induced demyelination
• PPI-induced nephritis.
Further information can be found at UK IBD Genetics Consortium and in the attached file.
- PRED 4 [ 32 kb ]
Two CCRN-supported hepatology trials
Primary Biliary Cirrhosis (PBC) Genetics and Primary Sclerosing Cholangitis Studies
Hepatology Specialty Group
The PBC Genetics Study is a national effort to establish a PBC DNA collection consisting of DNA samples from approximately 5000 patients with PBC. The study looks for variations in small fragments of DNA between 'healthy controls' and patients. The DNA collection will be used for a genome-wide association study (GWAS) of PBC and future genetic studies. Recruitment started in Cambridge, expanded to include East Anglia and transplant centres, and is now recruiting nationally. Getting the CCRN on board made an enormous difference to getting more participants into the study. We now have a co-ordinator in Cambridge who directs nurses around the country to identify patients and collect data, which he then collates. Recruitment in the fourth year of the study is now running at 60 - 100 patients a month with total recruitment at over 4,000 which (with about 12000 - 15000 patients recruited nationally) is staggering.
Clinical Trials Update #4 March 2011
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