32.jpg)
56.jpg)
Non-invasive method for the diagnosis and screening of colorectal cancer and advanced adenomas in asymptomatic individuals
ES2683866
The invention relates to the development of an in vitro method for diagnosing colorectal cancer and advanced adenomas in asymptomatic individuals, by means of a test in a human biofluid, preferably serum. It consists in the joint quantification of sCD26 and NDKA proteins by specific immunoassays, and the percentage of methylation of the NEUROG1 gene by means of real-time PCR specific for methylation. The combination of the three markers by multivariate logistic regression will result in a calculated risk score for colorectal cancer or advanced adenomas, which is compared to an established cut-off point. If the test is positive, a confirmatory colonoscopy is recommended. On the contrary, if the result is negative, it is recommended to repeat the test in one year. This non-invasive method is a very useful tool for the diagnosis of colorectal cancer and advanced adenomas to be used in screening programs in asymptomatic individuals.
This analysis will be helpful to the clinician and it will allow them, based on a calculated neoplasia risk score advanced (CCR or AA) for each individual and its comparison with a cut-off point established, to know if the individual has an increased risk of presenting CRC or AA, with 10 the subsequent recommendation to undergo a colonoscopy for diagnosis. On the contrary, in the case of individuals who, according to the calculated score, do not present risk of NA, the clinician will consider that it is not necessary to perform a colonoscopy at that time and this will prevent the subject from undergoing an invasive test such as colonoscopy, which carries an associated risk of complications.