The Northern-European Initiative on Colorectal Cancer

Colorectal Cancer Clinical Trial

— NordICC  

Official title:

NordICC The Northern-European Initiative on Colorectal Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00883792
• Other study ID #: NordICC
• Status: Active, not recruiting
• Phase: Phase 3
• First received: April 17, 2009
• Last updated: June 16, 2017
• Start date: May 2009
• Est. completion date: July 2036

Study information

• Verified date: June 2017
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 95000
• Est. completion date: July 2036
• Est. primary completion date: June 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 64 Years

Eligibility

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)

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• Colonoscopy
Once-only colonoscopy screening

Locations

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

Sponsors (8)

Lead Sponsor	Collaborator
Oslo University Hospital	Erasmus Medical Center, Harvard School of Public Health, Karolinska Institutet, Landspitali University Hospital, Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology, Memorial Sloan Kettering Cancer Center, Uppsala University Hospital

Countries where clinical trial is conducted

United States,  Iceland,  Netherlands,  Norway,  Poland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		15 years after screening (interim analysis after 10 years)
Secondary	CRC mortality and CRC incidence of screening attendees compared to the control group and non-attendees		15 years after screening (interim analysis after 10 years)
Secondary	Mortality from all causes		15 years after screening (interim analysis after 10 years)