Biomarker Project

Our large biomarker project

 

Current research schedule

Spring 2014–December 2023 incl. final results

with up to 30.000 participants:

UK_Hieraki
CLICK

 

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 a 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:

PART 1:

  • Positive:   Blood samples (90 ml) and data collected from 8,000 subjects, who have been screened positive using the Fecal Immunological Test (FIT+); hence, undergone the subsequent colonoscopy to identify the source of occult blood in the feces. Before the colonoscopy blood samples have been collected and the pre-examination data recorded. As well as, the post-colonoscopy data, including findings, diagnosis, possible intervention and final result have been recorded in the web-based database.

•   The blood samples have been handled, and stored at -80C within two hours at each of the local hospital
•   All frozen samples have gotten long-term stored at Hvidovre Hospital (-80C; 24/7 electronic surveillance)
•   The results of the colonoscoies hve been recorded in our web-based database

    • The study inclusion was finalized by August 20168,176 subjects were included
    • The FIT-positive blood sample analyses are being compared with the results of the colonoscopies
  • Negative:   Blood samples (90 ml) and data collected from 5,000 subjects, who have been screened negative using the Fecal Immunological Test (FIT-); hereafter referred to a next, subsequent FIT screening in four years. Within 30 days after the FIT- subject received the test result, he/she received an electronic invitation to participate in the Endoscopy III, part 1- study. 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 20165,118 subjects were included
    • The FIT-negative blood sample analyses are compared with the results from 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 in procedure

PART 2:

  • Part 2 A+B:   From September 2016 blood samples (90 ml) and data have been collected from 30,000 subjects, who have been screened negative using the Fecal Immunological Test (FIT-).
    Inclusion in the study requires that the subject 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 are collected and recorded in the web-based database at the local (participating) hospital.

    • The part 2A-study: inclusion of the first blood-and data set from about 30,000 with a FIT-negative
      is to be concluded ultimo February 2018.
    • The part 2B-study: inclusion of the second and third blood-and data set (after 2 and 4 years) will be conducted parallel to laboratory analyses, statistical calculations, etc. from medio 2018-2022
    • 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 since have developed
    one of the diseases included in the project
  • Thus, validating the ability of the biomarkers to identify cancer diseases under development

 

fakta_bg
Analyses

Research sites:

  • The Clinical Part:
    Collection of blood samples, data and records

is carried out by the 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
medarbejder-remse
Staff members (DK)

At present, 40 persons are employed by our two, parallel ongoing studies distributed at the above hospitals.

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.

  • The Biochemical Part:
    Analyses and statistical calculations

are carried out by academic and commercial collaborating laboratories
—according to signed cooperation 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.

 

Budget and financing:

  • 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.

Cf. Sponsors

 

Read more:

circle-blue-en-2

Protocol Outlines      Analyses

The triage project      A feasibility project

Screening-research History

 

Print Friendly, PDF & Email

Contact:

ColoRectal Cancer Research

Gastroenheden, Hvidovre Hospital

Kettegård Allé 30

2650 Hvidovre

Email: info@colorectalcancer.dk