Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Eligibility Criteria

Inclusion Criteria:

• This study is a population-based randomised controlled trial, with randomisation of individuals age 55-64 years living in the screening areas directly from the Population Registries to either screening group or control group. Eligible persons with the same home address will be randomised to the same group (household randomisation).

Exclusion Criteria:

• Individuals with previous colorectal surgery (resections, enterostomies)

• Individuals in need of long-lasting attention and nursing services (somatic or psychosocial, mental retardation).

• On-going cytotoxic treatment or radiotherapy for malignant disease

• Severe chronic (longer than trial duration) cardiac (NYHA III-IV)or lung disease

• Lifelong anticoagulant therapy with Warfarin

• A coronary event requiring hospitalization during the last 3 months

• A cerebrovascular event during the last 3 months

• Resident abroad

• Return of unopened letter of invitation and/or reminder (address unknown)

• Message from neighbour/family/post office on death of screenee (not updated in Population Registry)

Trial Contact Information

Trial Lead Organizations/Sponsors

Royal Norwegian Ministry of Health and Care Services

Hans-Olov Adami, MD PhD

Study Director

Michael Bretthauer, MD PhD

Principal Investigator

Geir Hoff, MD PhD

Study Chair

Michael Bretthauer, MD PhD		Ph: +4790132480
		Email: michael.bretthauer@rikshospitalet.no

Norway
	Oslo
	Cancer Registry of Norway
		Michael Bretthauer, MD PhD
		Michael Bretthauer, MD PhD	Principal Investigator
Poland
	Warsaw
	Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
		Jaroslaw Regula, MD PhD	Ph: 48 606 906 992
			Email: jregula@coi.waw.pl
		Michal Kaminski, MD PhD	Ph: 48 606 906 992
			Email: mfkaminski@coi.waw.pl
		Jaroslaw Regula, MD PhD	Principal Investigator
		Michal Kaminski, MD PhD	Sub-Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00883792
Information obtained from ClinicalTrials.gov on November 20, 2012

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