NCT00883792Active, not recruitingPhase 3
The Northern-European Initiative on Colorectal Cancer
NordICC The Northern-European Initiative on Colorectal Cancer
Source: ClinicalTrials.gov · Last updated 19 Jun 2017
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 95000 (actual)
- First submitted
- 17 Apr 2009
- Start date
- May 2009
- Primary completion date
- Jun 2026
- Lead sponsor
- Oslo University Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT00883792
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 95000
- From May 2009 to the primary completion date, Jun 2026
- 7 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Individuals with previous colorectal surgery (resections, enterostomies)
- Lifelong anticoagulant therapy with Warfarin
Other illness
- On-going cytotoxic treatment or radiotherapy for malignant disease
- Severe chronic (longer than trial duration) cardiac (NYHA III-IV)or lung disease
Other
- Individuals in need of long-lasting attention and nursing services (somatic or psychosocial, mental retardation).
- 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)
Who the study is looking for
- 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).
Age in the registry: 55 years to 64 years · Sex: All · Accepts healthy volunteers
Sites (7)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Landspitali University Hospital Coordinator of this site? Confirm its status | Reykjavik | Iceland | Unknown status |
| Erasmus University Medical Center Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| Oslo University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
| Maria Sklodowska-Curie Memorial Cancer Centre Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Karolinska Institute Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
| Harvard School of Public Health Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.