Ann-Sofie Backman

Due to implementation of organized colorectal cancer screening in Sweden and many other European countries, the number of patients with early-stage colon cancer are rapidly growing. This is a positive outcome of screening but demands more sophisticated minimally invasive treatment techniques.The SCAR trial is a randomized head-to-head comparison trial of patients who have undergone incomplete endoscopic removal (polypectomy, EMR) of early colon cancer (P) for complete and definitive treatment of the cancer. A novel minimally invasive treatment with colonoscope - endoscopic full-thickness resection (I) - will be compared to standard-of-care surgery (C). The 160 patients needed in each allocation arm, will be asked to be included in the trial at the endoscopy centers after eligibility assessment by the local multidisciplinary tumor board. The co-primary outcomes are adverse events (O1) and cancer recurrence (O2), estimated after 30 days of treatment and 3 years of follow-up (T), respectively. The secondary outcomes are quality of life, cost-effectiveness, and ecological footprint.With successful analyses in approximately 5 years after trial start, the results may lead to complete re-thinking of treatment approaches in these patients. There would be a tremendous potential in decreasing overtreatment with the advanced surgery used today, in favor of an as effective, but safer, endoscopic treatment that improves quality of life and that can be performed in an out-patient setting.

Colon cancer that runs in the family often causes the onset of cancer at a young age and leads to major consequences both on a human level and socioeconomically. The preventive strategy that prevails today is based on frequent colonoscopy examinations. In the event of cancer, it leads to extensive operations, often with lifelong gastrointestinal problems following. The possibilities for medical preventive treatment are incompletely studied and a tolerable preparation for lifelong preventive treatment is missing. In addition to preventive treatment, there is no possibility of early identification of cancer via other examinations such as blood tests instead of colonoscopies. The study investigates whether the drug Mesalamine can be used preventively to reduce the risk of colon cancer compared to an inactive substance (placebo). Mesalamine is a well-tolerated drug and has been used for over 30 years to treat inflammatory bowel disease. The drug appears to reduce the risk of developing colon cancer when examining the effect on tumors in animal experiments. Mesalamine is similar to aspirin, which is known to reduce cell changes in the intestine, but does not have the side effects, such as stomach ulcers and increased risk of bleeding, that aspirin has. The effect of Mesalamine on intestinal flora will be investigated. Early markers for cancer will be mapped in blood. The best cancer is the one that never occurs. Finding an effective and well-tolerated drug that prevents cancer development with the least possible side effects is especially important in this high-risk group, which needs to start life-long preventive treatment at a young age. We need to be able to offer an alternative to aspirin, which is linked to bleeding and gastrointestinal side effects. We will look at the number and type of new polyps in treated and untreated groups and the goal is to see if Mesalamine prevents malignant polyps and if the drug contributes to creating an environment in the intestine between intestinal flora and mucosa that prevents cell changes.