Current research schedule
Spring 2014–December 2023 incl. final results
with up to 30.000 participants:
Subsequent, to results of 4 major clinical studies conducted in Denmark and Australia
Endoscopy III [part 1 and 2]— our present major research project—is run on a screening relevant population without symptoms of colorectal cancer (CRC).
The project is designed as the final validation of, hitherto, retrieved results, which—as of this point—are obtained from subjects with symptoms of CRC;
thus, referred to diagnostic colonoscopy.
- The study including all the amendments is approved by:
The Ethics Committee: H-4-2013-050 (and amendments 39420, 39716, 42203, 43062, 48029, 52710) +
The Danish Data Protection Agency: RegionH 2007-58-0015 / HVH-2013-022/I-Suite no. 02324.
Outlines of the Endoscopy III study:
- Positive FIT-results: Blood samples (90 ml) and data were collected from 8,000 subjects, who were screened positive using the Fecal Immunological Test (FIT+); hence, undergone the subsequent colonoscopy to identify the source of the occult blood in the feces. Before the colonoscopy blood samples were collected and the pre-examination data recorded. As well as, the post-colonoscopy data, including findings, diagnosis, possible intervention and final result were recorded in the web-based database.
• The blood samples were handled, and stored at -80C within two hours at each of the local hospital
• All frozen samples are long-term stored at Hvidovre Hospital (-80C; 24/7 electronic surveillance)
• The results of the colonoscoies were recorded in our web-based database
- The study inclusion was finalized by August 2016—8,176 subjects were included
- The FIT-positive blood sample analyses will be compared with the results of the colonoscopies
- Negative FIT-results: Blood samples (90 ml) and data were collected from 5,000 subjects, who were screened negative using the Fecal Immunological Test (FIT-); hereafter referred to a next, subsequent FIT screening in two years. All blood samples and data were collected and recorded in the web-based database at local (participating) hospitals.
- The study inclusion was finalized by March 2016—5,118 subjects were included
- The FIT-negative blood-sample analyses will be compared with the results form the FIT-positive study
- All data records have been subject to rigorous on-line and on-site audits
- The entire analyses of all data and blood samples are still under process
- The firsrt results from this project are expected during 2019
- PART 2:
- Part 2 A+B: From September 2016 blood samples (90 ml) and data were to be collected from about 30,000 subjects, who were screened negative using the Fecal Immunological Test (FIT-).
Inclusion in the study required that the subjectwould accept to provide a second and third blood and data collection after 2 and 4 years, respectively—linked to the nextcoming general offers of CRC-screening.
Hence, the blood samples and data were collected and recorded in the web-based database at the local (participating) hospital.
- The part 2A-study: inclusion-round 1 of the first blood-and data set from all together 32.665 subjects with a FIT-negative were concluded by ultimo February 2018.
- The part 2B-study: inclusion of the second-and third-round blood-and data set (after 2 and 4 years) began at March 2018.
By June 2019 13,918 from the first round were included the second time
(inclusion rates keeping up the expected 75% of round 1).
Inclusion rounds 2 and 3 will continue in the Capital Region.
Collection of all blood-and data samples are expected to be concluded by ultimo 2022.
- Estimations are that all final results will be available during 2023
- The level of the biological markers in the analyzed blood samples will be compared with databases
that can identify project participants who had or after wcreening have developed
one of the diseases included in the project
- Thus,this project will validate the ability of the biomarkers in blood to identify cancer diseases under development
- The Clinical Part:
Collection of blood samples, data and records
is carried out by screening centers at 10 cooperating hospitals
- The Capital Region:
Amager-Hvidovre, Bispebjerg, Herlev and Hillerød Hospitals
- The Central Region of Denmark:
Herning, Horsens, Holstebro, Randers, Silkeborg and Viborg Regions Hospitals
Up to 40 employees distributed at the above hospitals are performing our two, ongoing parallel studies: Endoscopy III + IV
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 studies within the group.
- The Biochemical Part:
Analyses and statistical calculations
are carried out by academic and commercial collaborating laboratories
—according to signed collaborations contracts.
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.
- The budget for the entire study [part 1 + 2 (2014–2023 incl.)]
—excluding analysis costs—is approx. 140 million DKK.
The study is financed partly by Danish and European private funds;
partly through collaborating laboratories—both academically and commercially based.
- All national and international academical 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 cooperation contracts.