Extrait

Background and study aims Colorectal (bowel) cancer is a common disease. Obesity is a major health problem and is a known risk factor for bowel cancer. Weight loss surgery is increasingly being used in the management of severe obesity. However, the effect of weight loss surgery on bowel cancer risk is not known. In our previous work we have developed a number of unique biomarkers of bowel cancer risk, which can be measured in small samples (biopsies) taken from the bowel during an examination of the bowel (rigid igmoidoscopy). We have shown that these biomarkers can be detected before the development of bowel cancer and so may be a useful tool to identify those at higher risk of the disease. This study will tell us if obesity and surgically induced weight loss can affect these biomarkers and as a result influence the risk of developing bowel cancer in the future. Who can participate? This study aims to recruit about 40 adult men and women who are planned for weight loss surgery. We also aim to recruit 20 healthy volunteers who are not overweight or obese. What does the study involve? Blood, urine and stool samples and bowel wall biopsies, as well as body measurements and data on dietary, lifestyle and bowel habits, will be collected from a group of obese patients before and six months after weight loss surgery. We will collect similar samples and data from healthy normal weight individuals to use as a comparison. We can then look for any changes in the expression of these biomarkers, as well as a number of other important cancer-related measures. What are the possible benefits and risks of participating? There will be no immediate direct benefit to those taking part. There is a very small risk of causing bleeding and an even smaller risk of causing a perforation (hole or tear) when taking biopsies from the bowel. Steps are taken to minimise these risks. Where is the study run from? North Tyneside General Hospital, UK. When is study starting and how long is it expected to run for? Participants will be enrolled on the study for a minimum period of one year starting from November 2013; however, the enrolment period may be extended if necessary. The study is expected to run until the end of April 2016. Who is funding the study? Northumbria Healthcare Foundation Trust, UK. Who is the main contact? Dr Sorena Afshar [email protected]

Critère d'inclusion

• Obesity; Colorectal cancer; Bariatric surgery

Liens

• isrctn
• ictrp