The Northern-European Initiative on Colorectal Cancer (NordICC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2011 by Norwegian Department of Health and Social Affairs
Sponsor:
Collaborators:
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Erasmus Medical Center
Landspitali University Hospital
Uppsala University Hospital
Karolinska Institutet
Riga Eastern Clinical University Hospital, Riga, Latvia
Memorial Sloan-Kettering Cancer Center
Harvard School of Public Health
Information provided by:
Norwegian Department of Health and Social Affairs
ClinicalTrials.gov Identifier:
NCT00883792
First received: April 17, 2009
Last updated: June 9, 2011
Last verified: June 2011

April 17, 2009
June 9, 2011
May 2009
June 2026   (final data collection date for primary outcome measure)
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 [ Time Frame: 15 years after screening (interim analysis after 10 years) ] [ Designated as safety issue: No ]
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 [ Time Frame: 15 years after screening (interim analyses after 5 and 10 years) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00883792 on ClinicalTrials.gov Archive Site
  • CRC mortality and CRC incidence of screening attendees compared to the control group and non-attendees [ Time Frame: 15 years after screening (interim analysis after 10 years) ] [ Designated as safety issue: No ]
  • Mortality from all causes [ Time Frame: 15 years after screening (interim analysis after 10 years) ] [ Designated as safety issue: No ]
  • CRC mortality and CRC incidence of screening attendees compared to the control group and non-attendees [ Time Frame: 15 years after screening (interim analyses after 5 and 10 years) ] [ Designated as safety issue: No ]
  • Mortality from all causes [ Time Frame: 15 years after screening (interim analyses after 5 and 10 years) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
The Northern-European Initiative on Colorectal Cancer
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Colorectal Cancer
Procedure: Colonoscopy
Once-only colonoscopy screening
  • Experimental: Colonoscopy screening
    One-time colonoscopy is the screening tool used in this trial. All individuals in the screening group will be offered a full colonoscopy. At colonoscopy, all detected CRC precursor lesions will be removed, whenever possible.
    Intervention: Procedure: Colonoscopy
  • No Intervention: Control

    The control group will not be offered any screening or intervention within the trial, but follow usual care in the participating countries. Individuals assigned to the control group will not be informed about their status as controls in the trial. This approach facilitates a truly population-based study, which will be used to estimate the effect of the screening intervention in the general population, mimicking national CRC screening programs.

    All ethics committees at the participating centres have approved the study protocol before recruiting individuals to the trial. In Sweden, the national ethics committee particularly reviewed the non-information of the control group and found it ethically acceptable.

Kaminski MF, Bretthauer M, Zauber AG, Kuipers EJ, Adami HO, van Ballegooijen M, Regula J, van Leerdam M, Stefansson T, Påhlman L, Dekker E, Hernán MA, Garborg K, Hoff G. The NordICC Study: rationale and design of a randomized trial on colonoscopy screening for colorectal cancer. Endoscopy. 2012 Jul;44(7):695-702. doi: 10.1055/s-0032-1306895. Epub 2012 Jun 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
66000
July 2036
June 2026   (final data collection date for primary outcome measure)

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)
Both
55 Years to 64 Years
Yes
Contact: Michael Bretthauer, MD PhD +4790132480 michael.bretthauer@rikshospitalet.no
Contact: Geir Hoff, MD PhD +4791866762 hofg@online.no
United States,   Iceland,   Latvia,   Netherlands,   Norway,   Poland,   Sweden
 
NCT00883792
NordICC
Yes
Geir Hoff, MD pHD and Michael Bretthauer MD PhD, The Cancer Registry of Norway
Norwegian Department of Health and Social Affairs
  • Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
  • Erasmus Medical Center
  • Landspitali University Hospital
  • Uppsala University Hospital
  • Karolinska Institutet
  • Riga Eastern Clinical University Hospital, Riga, Latvia
  • Memorial Sloan-Kettering Cancer Center
  • Harvard School of Public Health
Study Director: Hans-Olov Adami, MD PhD Harvard School of Public Health, Boston, USA
Principal Investigator: Michael Bretthauer, MD PhD The Cancer Registry of Norway
Study Chair: Geir Hoff, MD PhD The Cancer Registry of Norway
Norwegian Department of Health and Social Affairs
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP