Validation of Triage
in Selection to Diagnostic Colonoscopy
among subjects with symptoms
attributable to colorectal cancer
The ENDOSCOPI IV – project:
(project inclusion fully implemented by early Spring 2019—conclusion medio 2021)
(1) a person’s age + (2) a FIT- test (=test for occult blood in feces) + (3) a blood-based cancer-associated biomarker test
has shown a much more accurate selection for colonoscopy than screening based on a FIT-test alone.
Now, this concept is validated for selection to diagnostic colonoscopy.
Over a 2-year-period, the project will include 1,500 subjects
referred to colonoscopy due to symptoms of CRC.
Presumably, the use of Triage may reduce the overall need for colonoscopy
also in diagnostic colonoscopy among subjects with symptoms attributable to CRC.
The Endoscopy IV- results could be of major national as well as international value:
- in health economics
- reduced waiting time
- for those who avoid an unpleasant examination
with possible risk as a side effect.
The project with additional protocols has been approved by
the Ethics Committee of the Capital Region of Denmark (H-17031325) and the Danish Data Protection Agency.
Outlines of the Endoscopy IV study:
THE CLINICAL PART / Part A
Start-up as a pilot project Oct.2018—
fully implemented by early Spring 2019-medio 2021:
Collection of blood samples, data and records
from 1,500 subjects referred to colonoscopy due to symptoms of CRC.
is carried out by the Endoscopy centers at 5 collaborating hospitals:
- Amager-Hvidovre Hospital, Bispebjerg, Herlev and Hillerød Hospitals in the Capital Region
Aims are to include approximately 150 subjects diagnosed with CRC, and 275 subjects with adenomas:
- A combination of the person’s age + the person’s results of a FIT-test + a blood-test for cancer-associated biomarkers
will be assessed in relation to findings of the colonoscopy.
- Thus, validating the selection efficacy of using the Triage–concept
for diagnostic colonoscopy of subjects referred due to symptoms of CRC.
THE BIOCHEMICAL PART/ Part B
medio 2021-medio 2022:
Analyses and statistical calculations
are carried out by collaborating academic and commercial laboratories
—according to signed collaboration contracts (plus MTAs).
Note: all analyses performed by collaborators do not burden the project financially:
- The collected blood samples will be used for analyses of
proteomics, genomics, epigenomics, transcriptomics and metabolomics.
- The results will be included in the overall statistically / bioinformatically
calculations based on a written, approved and signed SAP.
- Up to 40 employees distributed at the mentioned hospitals have been attached our two, parallel running studies—Endoscopy III + IV.
About 25 employees are still involved in the two parallel projects.
- The study initiator and PI is: Kornerup Professor Hans Jørgen Nielsen, MD, DMSc, Department of Surgical Gastroenterology 360, University of Copenhagen at Hvidovre Hospital, 2650 Hvidovre
- A steering committee and an executive board act as advisers of the study.
Budget and financing:
- The budget for the Endoscopy IV- project (2018–medio 2022)
—excluding analysis costs—is approx. 20 million DKK.
The project is financed partly by Danish and European private funds;
partly through collaborating laboratories—both academically and commercially based.
- All national and international academic and commercial laboratory collaborations
are based on a keen interest in access to our comprehensive, well-documented test material.
- All collaborations are conducted according to signed collaboration contracts. Cf. Sponsors
Perspectives of the project-results:
- possible concepts for reducing the overall number of colonoscopies
have been on the program at the latest meetings in
Early Detection Research Network at National Cancer Institute, Bethesda, USA
CRC-screenings should gradually be offered all citizens between 40 and 85 years of age—
—(where, the current recommendations are: all 50-74 years of age; used in Denmark)
Today, an increasing number of young people—under the age of 50—
are diagnosed with the CRC-disease.
At the same time, the population is getting older and older—and maintain a continued healthy life.
As consequence of the health-economic system in the United States where self-financing is required:
- many—having a screening-test with elevated FIT-results—will develop
a CRC-disease before deciding on a costly, subsequent colonoscopy.
A blood test after a FIT-screening would emphasize the necessity of a possibly urgent colonoscopy.
The publications on the basic research results: