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Clinical Trials in the Netherlands / NCT00883792
Active, not recruiting Phase 3

The Northern-European Initiative on Colorectal Cancer

NCT00883792 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Oslo University Hospital
Phase
Phase 3
Started
2009-05
Last updated
2017-06-19

Condition(s) studied

Colorectal Cancer

Investigational drug(s) / intervention(s)

Colonoscopy

Colonoscopy: Once-only colonoscopy screening

Study 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

Sex
ALL
Min age
55 Years
Max age
64 Years
Healthy volunteers
Accepted
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)

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
Harvard School of Public Health Boston Massachusetts
Memorial Sloan-Kettering Cancer Center New York New York
Landspitali University Hospital Reykjavik Iceland
Erasmus University Medical Center Rotterdam Netherlands
Oslo University Hospital Oslo Norway
Maria Sklodowska-Curie Memorial Cancer Centre Warsaw Poland
Karolinska Institute Stockholm Sweden

More Oslo University Hospital trials in the Netherlands

DAPAgliflozin for Renal Protection in Heart Transplant Recipients Active, not recruiting
Effect of Breastfeeding on Lipid Profile and Cardiovascular Risk Markers in Women With Familial Hypercholesterolemia Active, not recruiting
Multi-Site Eating Disorder Prevention Program for Type 1 Diabetes Active, not recruiting

Other trials for the same condition

A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors Recruiting
Follow-up After Surgery for Colorectal Cancer Active, not recruiting
Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors Recruiting
COLLISION RELAPSE Trial Recruiting
Prospective Data Collection Initiative on Colorectal Cancer Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT00883792 on ClinicalTrials.gov ↗ ← All trials in the Netherlands