The Northern-European Initiative on Colorectal Cancer



Status:Recruiting
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:55 - 64
Updated:4/2/2016
Start Date:May 2009
End Date:July 2036
Contact:Michael Bretthauer, MD PhD
Email:michael.bretthauer@rikshospitalet.no
Phone:+4790132480

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NordICC The Northern-European Initiative on Colorectal Cancer

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.


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)
We found this trial at
2
sites
1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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25 Shattuck Street
Boston, Massachusetts 02115
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Boston, MA
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