Triage at diagnostic colonoscopy

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)


The TRIAGE-concept:

(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.

cf:  Triage in screening for colorectalcancer

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:

Research Schedule and Sites:



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.



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:



  • 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
  • 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:


Primarily because:

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.


Read more:

Why Triage        Application of research results

The publications on the basic research results: 

Triage for selection to colonoscopy?

Serological biomarkers in triage of FIT-positive subjects?

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ColoRectal Cancer Research

Gastroenheden, Hvidovre Hospital

Kettegård Allé 30

2650 Hvidovre