Early detection (screening)
The primary aim of the research is to develope a screening concept for early detection of large bowel neoplasia based on cancer-associated biomarkers in blood. A concept targeting those who do not wish to be screened with a FIT-test and as such could be a supplement to the usual FIT-test in screening.
Ultimately, this could provide considrably improvement of screening compliance compared to a FIT-test, alone.
The secondary aim is to develop an additional blood-based diagnostic test, which may find subjects with extra-colonic malignancy among those subjects who are not detected by the feces-based FIT test and subsequent colonoscopy.
Previous and current large clinical research studies have included > 65,000 subjects—in Denmark (97%) and Australia (3%)— either with symptoms attributable to large bowel neoplasia or following a FIT-test.
Our current research programs in the development of blood-based screening have shown high compliance rates
Our research concept is based on a combinations of molecules/fragments/mutations from the proteomic, genomic, epigenomics, transcriptomic and metabolomic areas
in order to:
- Identify subjects with colorectal cancer—all stages
- Identify subjects with adenoma lesions—at least high-risk and medium-risk stages
- Identify subjects with extra-colonic malignancy
- Identify interval cancer—subjects at the risk of developing adenoma or colorectal cancer before the next screening round. (Persons who, consequently, should be offered frequent screening)
Possible future implications: Follow-ups with frequent blood-based tests may reduce the number of subjects that, with time, are at risk of being diagnosed with neoplastic diseases substantially tests may reduce the number of subjects diagnosed with neoplastic diseases, substantially.
Presently, 5,330 (2018) are diagnosed with colorectal cancer every year, in Denmark. Mainly, diagnosis are based on examination of subjects with symptoms attributable to neoplastic bowel lesions. At the time of diagnosis approximately 50% have early stage disease (stage I or II); most patients will be cured in these stages. The other 50% have late (disseminated) stage disease (stage III or IV)—stages where curative interventions are not always successful.
Early detection is important and often decisive for complete curable treatment.
Population screening is the most efficient in detecting subjects who without any symptoms have an intra-colonic neoplastic lesion. By screening such patients may have an increased chance of curative interventions.
Screening improves the overall patient survival
Screening reduces incidence of neoplastic bowel lesions
Present population screening is based on an immunological test for occult blood in feces (FIT). Currently, the most recognized test (state of the art) of all the available screening-tests..
Even though, a few improvements are desirable:
1. The FIT test has a sensitivity of 79% at 95% specificity.
However, the current compliance rate is 62% Thereby, the clinical sensitivity is only 49% (79 X 62%) Hence, 51% of those in the screen relevant population that have a neoplastic lesion are not identified by the FIT test.
The collaborative national and international research in blood-based biomarker screening concepts aim to develop a test with improved efficacy and compliance.
2. Among all screening-derived colonoscopies due to a positive FIT-test onnonly around 30% show a finding of a disease or a treatment demanding neoplastic bowel lesion.
Consequently, to develope a screening concept capable of a more precise selection to colonoscopy of subjects in risk of the disease CRC or adenomas is highly desirable.
Current research projects
Hitherto, all our achieved research results have been based on blood samples and data from subjects with symptoms that directed diagnostic colonoscopy. Subsequently:
the present project is validating our screening concept for early detection
parallel to a regular screening of subjects between 50-74 years of age
—without symptoms of CRC—in the Danish general public screening for colorectal cancer
Our final – and largest – project so far!
By May ’20 the project concluded the inclusion round 2 including all together 15,978 blood-and data sets the second time from the 32,665 subjects included in round 1.
The project inclusion round 3 proceeds at Amager-Hvidover Hospital/ The Capital Region.
This project is the required final validation of our screening-concept — and aims to enable future clinical use of a screening test based on cancer-associated biomarkers in blood
continue to assist in the current research project
Give your blood sample no. 3 for the project — (cf invitation letter)
2. Endoscopy IV—Triage in selection for diagnostic colonoscopy of subjects
with symptoms attributable to colorectal cancer:
to identify only those subjects with an absolute need for a colonoscopy among subjects with symptoms of CRC and, therefore, referred to diagnostic colonoscopy.
Due to the success of the general population screening for colorectal cancer
the overall requirement of colonoscopies—screening, diagnostic and adenoma control—far exceeds
the Danish examination capacity, in total
The Endoscopy IV-project will be conducted in parallel to the Endoscopy III
at the 5 collaborating hospitals in the Capital Region of Denmark.