Development of a blood-based biomarker concept for screening of CRC
Every year 5,400 Danes (2017) are diagnosed with primary colorectal cancer (CRC). Due to lack of evident symptoms, more than half of these do have disseminated disease at the time of diagnosis. Thereby, complete and effective treatment is far from always achievable. Currently, screening based on an immunological test for occult human blood in feces (the FIT test) has been implemented to improve the overall prognosis and reduce the incidence of the disease. At present the compliance in FIT-screening in Denmark is 62%, and the sensitivity of the FIT-test is 79%—this leads to a clinical sensitivity of 49%. Long story short: 51% of the those, who in the screen relevant population may have a neoplastic bowel lesion will not be identified.
The present colorectal cancer research includes development of a screening concept based on
cancer-associated biological markers in blood samples.
Such a concept could, possibly, be introduced as a supplement targeted at those who do not want screening
with a stool sample at the current screening;
and, possibly, improve the compliance in the current general screening.
is our largest ever—and the definitely final evaluation of our research towards a screening model for colorectal cancer based on blood samples.
Endoscopy III-Part I is now completed and ran parallel to the public, general screening for colorectal cancer from 2014 to 2016.
Part II runs until the summer 2022.
The project is a collaboration between screening centers at 10 hospitals in Denmark— 4 in the Capital Region and 6 in the Region Middle Jutland.
The project is managed from Hvidovre Hospital.
With the screening for colon cancer, the need for colonoscopy exceeds the capacity in Denmark. Approx 50-70% of all colonoscopies are without any findings.
A combination of (1) age + (2) a blood test + (3) a test for occult blood in feces (FIT) can more accurately identify for whom colonoscopy is required.
The TRIAGE test will be validated in 5 Danish hospitals. Expectations are that the need for colonoscopy can be reduced significantly.
Research focusing on analyses of feces-, blood- and tissue samples to identify a causal relationship between fecal bacterial, viral and fungi DNA and mutations in epithelial bowel cells and subsequent development of CRC.
Research in screening for cancer based on blood samples. Biomarkers in blood can identify cancer diseases under development.
The earlier the diagnosis - the greater chances of complete cure. Use of blood samples for screening would increase the uptake.
Research in development of a blood-based test of biological markers to detect recurrence at an early stage. Early detection is urgent to offer renewed options for curative treatments.
Collaborative research including preanalytical, analytical and post-analytical issues—a validation of materials, databases, and audit issues.
Our current project—Endoskopi III─is comprised of two main work phases:
The collection of blood samples, data and records are carried out by the screening centers at 10 cooperating hospitals in Denmark:
The analyses of all the blood samples and all statistical calculations are carried out by our contractually-based collaborations with national and international biotech companies as well as leading Danish, American and European research institutions and hospitals:
Biological markers in blood may identify subjects at risk of developing subsequent cancer diseases
Our basic research-hypothesis is confirmed as we have now shown that:
elevated levels of one or more of four biological blood-based biomarkers relate to an increased risk of developing a cancer disease within few years.
Triage in screening for colorectal cancer
Potentially will future screening based on a combination of the current FIT-screening result added the person’s age plus the result of a blood-based biomarker test
reduce the total number of colonoscopies─ executed as a result of a screening based on a FIT-test─by 25%.
and spare the individual an unnecessary, unpleasant examination.
Read: The publication on the basic research results / published 08.03.2017