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NordICC - The Nordic-European Initiative on Colorectal Cancer

NordICC is a multicentre, randomised trial in Nordic countries, the Netherlands and Poland. NordICC is the first randomised trial investigating the effect of colonoscopy on Colorectal cancer incidence and mortality.

NordICC summer meeting 2012. Most of the Kristiansand and Arendal groups were present. Photo: Michael Bretthauer

About the project

Colorectal cancer (CRC) is a major burden in western countries. The disease develops from precursor lesions during a long time-interval. Colonoscopy can detect and remove CRC precursor lesions and may thus be effective for CRC prevention.

Read more about colorectal cancer screening.

Objectives

The primary study aims are CRC incidence and CRC mortality after 15 years of follow-up. The aim of the trial is to address the efficacy of colonoscopy screening.

Outcomes

Background

NordICC is a multicentre, randomised trial in Nordic countries, the Netherlands and Poland. A minimum of 66 000 individuals, age 55-64 years, are randomly drawn from the population registries in the participating countries. 22 000 are invited for once-only colonoscopy (2:1 randomisation). Expected work-load with 50% compliance will be 11 000 colonoscopies.

At the screening examination, all detected lesions are biopsied and removed whenever possible. The remaining 44 000 individuals (control group) are not offered any screening examination (care as usual).The primary study aims are CRC incidence and CRC mortality after 10 years of follow-up. In an intention-to-screen approach, a risk reduction of CRC mortality of 25% in the colonoscopy screening group compared to the control group is expected after 10 years follow-up, estimating 50% compliance in the screening group.

The NordICC trial is registered at ClinicalTrials.gov with registration no: NCT00883792.

ColoReg user guide (pdf)

Financing

Grants from the Polish and Dutch governments cover 7.500 colonoscopies performed in these respective countries starting in May 2009. The Research Council of Norway and the Nordic Cancer Union has funded the Norwegian participation. The Swedish participation is fundet by The Swedish Cancer Society.

Cooperation

  • Harvard T.H Chan School of Public Health, Boston
  • Marie Curie Sklodowska, Warsaw
  • Karolinska Instituttet, Stockholm
  • Sloan Kettering Memorial, New York City
  • Uppsala Universitetssykehus, Uppsala
  • Landspitali, Reykjavik
  • Erasmus Medical Centre, Rotterdam
  • Sørlandet Hospital, Kristiansand
  • Sørlandet Hospital, Arendal

Sub-study: Survey of risk factors

During 2014 a questionnaire on four risk factors associated with colorectal cancer (CRC) will be distributed to a randomized sample of the non-screened population of the NordICC-study. The questionnaire includes questions on smoking habits, comorbidity (coronary heart disease, stroke, diabetes), overweight and family history of colorectal cancer. The non-screened group consists of the individuals drawn to be in the control group and individuals who were invited to, but did not undergo the endoscopy examination. From this group a sample of 7000 individuals has been randomized to be recipients of the survey. The individuals who underwent the colonoscopy screening in the study have answered the same questionnaire. The data from the questionnaire will be compared with national registers.

The survey data will give valuable information on risk factors for colorectal cancer in the population, and the overall effect of the colonoscopy screening in 10 and 15 years.

Start - Finish

2009-2024

The NordICC study started in Poland and The Netherlands in May 2009. The first screeningcentre in Norway opened in Kristiansand in January 2011, followed by Arendal in May 2012. Seven centres in Sweden started in April 2013. The clinical part (colonoscopies) was finished in June 2014. The effect of colonoscopy on CRC incidence and mortality will be examined through national registries at 10-  and 15-year follow-up.

 

Tags: Nordic
Published Nov. 8, 2012 4:10 PM - Last modified June 7, 2017 9:47 AM