The Northern-European Initiative on Colorectal Cancer (NordICC)
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. Many national and international health organisations demand evidence from randomised trials to reduce incidence or mortality of the target disease before advocating population-wide cancer screening. However, while colonoscopy screening for the prevention of colorectal cancer is established in the United States and several European countries, no randomised trials exist to quantify the possible benefit of colonoscopy screening. NordICC is a randomised trial investigating the effect of colonoscopy on CRC incidence and mortality.
NordICC is a multicentre, randomised trial in Nordic countries, the Netherlands and Poland. A minimum of 66 000 individuals, age 55-64 years, are drawn randomly 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 15 years of follow-up, with an interim analysis after 10 years of follow-up. In an intention-to-treat 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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Prevention
|Official Title:||NordICC The Northern-European Initiative on Colorectal Cancer|
- Comparison of the screening group vs. the control group in an intention-to-treat model after 15 years of follow-up with regard to CRC mortality and CRC incidence [ Time Frame: 15 years after screening (interim analysis after 10 years) ]
- CRC mortality and CRC incidence of screening attendees compared to the control group and non-attendees [ Time Frame: 15 years after screening (interim analysis after 10 years) ]
- Mortality from all causes [ Time Frame: 15 years after screening (interim analysis after 10 years) ]
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||July 2036|
|Estimated Primary Completion Date:||June 2026 (Final data collection date for primary outcome measure)|
Experimental: Colonoscopy screening
One-time colonoscopy is the screening tool used in this trial. All individuals in the screening group will be offered a full colonoscopy. At colonoscopy, all detected CRC precursor lesions will be removed, whenever possible.
Once-only colonoscopy screening
No Intervention: Control
The control group will not be offered any screening or intervention within the trial, but follow usual care in the participating countries. Individuals assigned to the control group will not be informed about their status as controls in the trial. This approach facilitates a truly population-based study, which will be used to estimate the effect of the screening intervention in the general population, mimicking national CRC screening programs.
All ethics committees at the participating centres have approved the study protocol before recruiting individuals to the trial. In Sweden, the national ethics committee particularly reviewed the non-information of the control group and found it ethically acceptable.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00883792
|United States, Massachusetts|
|Harvard School of Public Health|
|Boston, Massachusetts, United States|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States|
|Landspitali University Hospital|
|Erasmus University Medical Center|
|Oslo University Hospital|
|Maria Sklodowska-Curie Memorial Cancer Centre|
|Warsaw, Poland, 02-781|
|Study Director:||Hans-Olov Adami, MD PhD||Harvard School of Public Health, Boston, USA|
|Principal Investigator:||Michael Bretthauer, MD PhD||Oslo University Hospital|
|Principal Investigator:||Michal Filip Kaminski, MD PhD||Marie Cure Sklodowska Cancer Center|