Early detection (screening)
The primary aim of the research is development of a blood-based screening concept for early detection of large bowel neoplasia. 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 diagnosed by the feces-based FIT test and subsequent colonoscopy. Previous and current large clinical research studies have included > 20,000 subjects—in Denmark and Australia— with symptoms attributable to large bowel neoplasia. Our current research programs in development of blood-based screening have shown high compliance rates
The concept is based on combinations of molecules/fragments/mutations from the proteomic, genomic, epigenomics, transcriptomic and metabolomic area 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 pre-or colorectal cancer before the next screening round. (Persons who, consequently, should be offered frequent screening)
Possible future implications: Frequent blood-based tests may reduce the number of subjects diagnosed with neoplastic diseases substantially
Presently, 4,250 Danes get the diagnosis of colorectal cancer every year. Mainly, the diagnosis is 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 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 75% at 90–95% specificity.
However, the current compliance rate is 64% Thereby, the clinical sensitivity is only 48% (75 X 64%) Thereby, 52% of those in the screen relevant population that have a neoplastic lesion is not identified by the FIT test.
The collaborative national and international research in blood-based biomarker screening concepts will develop a test with improved efficacy and compliance.
2. Among all screening-derived colonoscopies due to a positive FIT-test onnonly 30% show a finding of a disease or a treatment demanding neoplastic bowel lesion.
Consequently, a, further, focus point in our research has bcome to develope a concept capable of a more precise selection to colonoscopy of subjects in risk of the disease CRC or adenomas.
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 now the project has initiated inclusion round 2: the second round of collecting data and blod tests from the 32,500 subjects included in the project round 1 during the past 1.5-2 years
This project is the required final validation of our screening-concept — and aims to enable future clinical use of a blood-based screening test.
continue to assist in the current research project
Give your blood sample no. 2 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 last 4 years with the general 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 9 collaborating hospitals in the Capital Region of Denmark and the Central Region of Jutland