ORACLE (ctDNA)
Aim
This study aims to evaluate whether circulating tumour DNA (ctDNA) can be used to differentiate between patients with benign rectal polyps and early rectal cancers. This would improve treatment stratification, allowing the right treatment to be used for the right patient.
Study design
The study is a national, multidisciplinary collaboration involving centres across all five Danish regions.
About the project
The management of patients with large rectal polyps (> 2.5cm) is a major clinical dilemma. Despite appearing benign, between 20-30% of these polyps will contain an early-stage rectal cancer. Current diagnostic tests are not able to robustly differentiate between these groups and the diagnosis is only confirmed once the polyp is removed and examined by a pathologist. This causes major issues in treatment allocation. There are two main techniques for removing large rectal polyps, one of which is more suited to benign polyps and the other to early cancers. Using the wrong technique can have dire consequences, including the need for major surgery and permanent stomas.
If ctDNA proves capable of distinguishing between benign polyps and early-stage rectal cancer, it could pave the way for more targeted treatment strategies. Patients with benign polyps could undergo less invasive, local procedures, while those with cancer could be referred for advanced surgical treatment. This would improve the overall quality of treatment, reduce the risk of complications, and lower healthcare resource utilisation.
Research area:
Funding:
- Funding from DCCC facilitates the coordination of start-up meetings with participating centres, supporting efficient study initiation and maximising patient inclusion across centres.