Cancer biomarker detection in non-invasively sampled colorectal mucus
Research type
Research Study
Full title
Colorectal cancer detection by quantifying biomarkers in non-invasively collected colorectal mucus.
IRAS ID
218945
Contact name
Alexandre Loktionov
Contact email
Sponsor organisation
DiagNodus Ltd
Clinicaltrials.gov Identifier
ISRCTN16782445, ISRCTN Register
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Colorectal cancer (CRC), also known as bowel cancer, is the third most common cancer. It constitutes a global healthcare problem, causing almost 700,000 deaths worldwide every year. This disease usually affects people over the age of 50 and does not produce symptoms at its early stages. Very often CRC is detected too late to be successfully treated. Early detection of this cancer, especially through population screening, saves lives, but the existing non-invasive diagnostic tests used for this purpose are either insufficiently sensitive or excessively expensive. In addition, patient compliance is negatively affected by the requirement to collect and prepare stool samples for testing. DiagNodus Ltd has recently developed a new patient-friendly technique for non-invasive collection of highly informative colorectal mucus. Our recently completed study has proven that the new method provides samples suitable for measuring diagnostic biomarkers allowing reliable detection of inflammatory bowel disease (IBD). As it is well known that CRC similarly produces dramatic changes in colorectal mucus, it is highly likely that CRC biomarkers can be found in this material as well. The principal aim of this study is to examine if the new approach devised by DiagNodus Ltd is suitable for detecting CRC.
In the proposed pilot project at least 65 patients with CRC and 65 tumour-free patients will be recruited. All these patients will have their diagnoses confirmed by colonoscopy and histopathology, i.e. patients will be recruited following colonoscopy, once its result is known. Each patient will be provided with a kit for sample collection and instructed to collect two consecutive samples of colorectal mucus. All samples will be subjected to laboratory analysis for the presence of CRC biomarkers. Biomarkers providing the best diagnostic outcome will be selected for the development of a rapid point of care test for CRC early detection and screening.REC name
London - South East Research Ethics Committee
REC reference
16/LO/2273
Date of REC Opinion
30 Dec 2016
REC opinion
Favourable Opinion