Patient data registries: An invaluable resource for research By Glen Saffery, Coordinator, Bowel Disease Research Foundation Published: 30 January 2019 Patient data is an invaluable resource for our research. It helps us look at the outcomes of treatment for bowel disease and to pinpoint where and why variations exist. In short - we get a clearer picture of which treatment decisions work well, and can compare different options against each other to make sure patients get the best available care. Sometimes, genuinely life-changing breakthroughs come about through looking at this information. BDRF funded the OnCoRe registry to provide compelling evidence that thousands of rectal cancer patients can safely be spared major surgery. Its success is already leading to shifts in NHS practice that will have big impacts on people’s lives. When we initially funded OnCoRe back in 2013, it was a project with the goal of proving that major surgery could be avoided in the 10-15% of rectal cancer patients whose tumour was completely eradicated by radiotherapy. It has gone on to become something we never imagined - the largest database of its kind for this group of patients in the UK, and one of the largest in the world. Our task now is to see it fulfil its huge potential – to increase our understanding of this group of patients, and transform treatment for people with rectal cancer even further. Standard practice had always been to perform radical surgery to remove the rectum as a safety measure against cancer regrowth, even in people with no evidence of cancer after radiotherapy. Surgical removal of the rectum is a gruelling operation that has lifelong consequences, including in many cases a permanent colostomy. Researchers at the Christie Hospital in Manchester however believed that patients who had this ‘complete response’ could be cared for with a ‘watch and wait’ approach, i.e. regular follow-ups to check whether cancer had returned. They set up the OnCoRe registry to track the outcomes of patients managed by these alternative pathways – with results published in the Lancet oncology that strongly supported their hypothesis. Professor Andrew Renehan, who led the work, explains: “When we started OnCoRe, there was concern from oncologists and surgeons that by not operating on patients with rectal cancer, they would be leaving residual disease that could spread and have adverse consequences for patients. Thanks to the generous funding from BDRF, we were able to convincingly show that patients treated with the watch-and-wait approach don't do worse than those who had their tumours operated on when compared stage for stage, and in fact, they do marginally better. We believe these findings have contributed to centres implementing the watch and wait pathway into clinical practice, meaning that certain patients in the future will avoid undergoing a major operation and consequently, a permanent colostomy bag.” Having successfully demonstrated their findings, the team were left with a decision on what to do with the registry and the vital information it contained. Lee Malcomson, the data manager for the project, explains what happened next: “After the results from the initial OnCoRe registry were published in the Lancet Oncology, we were left with decision of what to do with the valuable dataset that had been compiled during the project. As this had become the largest dataset of its kind in the UK and one of the largest in the world, the decision was made to apply to the National Institute for Health Research to convert the existing registry into a Research Database and open recruitment to centres around the UK. There are 166 centres in the UK treating rectal cancer eligible for recruitment into OnCoRe, but only a small proportion are signed up so far. We need the support from Clinical Nurse Specialists, Colorectal Consultants and the R&D departments of these hospitals to get recruitment up and running.” Please spread the word to help us reach our goal of signing up all 166 centres offering radiotherapy treatment for rectal cancer. We believe every eligible patient should be offered the chance to be part of this, with the potential impacts being absolutely huge. Furthering our understanding of those patients lucky enough to have a complete response to radiotherapy is an extremely exciting opportunity – and the knowledge that could come from having a registry of them all in one place could see huge strides forward in care and treatment. Charity-supported registries can grow from something relatively small, like our initial study, into a world leading resource that transforms care around the world. Anyone considering setting one up, or donating to a medical research charity to improve care and treatment, should not hesitate! Further information about OnCoRe is available on www.complete-response.com and the latest updates are also available on Twitter (@OnCoRe_Study). As the OnCoRe Research Database is registered on the NIHR CRN Portfolio, all contributing trusts are eligible for support with recruitment. Please get in touch on [email protected] if you are from a trust that would like to participate.