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
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Procedure: Colonoscopy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: NordICC The Northern-European Initiative on Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Norwegian Department of Health and Social Affairs:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 66000
Study Start Date: May 2009
Estimated Study Completion Date: July 2036
Estimated Primary Completion Date: June 2026 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: Colonoscopy
Once-only colonoscopy screening
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.


  Eligibility

Ages Eligible for Study:   55 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00883792

Contacts
Contact: Michael Bretthauer, MD PhD +4790132480 michael.bretthauer@rikshospitalet.no
Contact: Geir Hoff, MD PhD +4791866762 hofg@online.no

Locations
United States, Massachusetts
Harvard School of Public Health Active, not recruiting
Boston, Massachusetts, United States
United States, New York
Memorial Sloan-Kettering Cancer Center Active, not recruiting
New York, New York, United States
Iceland
Landspitali University Hospital Not yet recruiting
Reykjavik, Iceland
Contact: Tryygi Stefansson, MD PhD         
Principal Investigator: Tryggvi Stefansson, MD PhD         
Latvia
Riga Eastern Clinical University Hospital Not yet recruiting
Riga, Latvia
Contact: Marcis Leja, MD         
Principal Investigator: Marcis Leja, MD         
Netherlands
Erasmus University Medical Center Completed
Rotterdam, Netherlands
Norway
The Cancer Registry of Norway Recruiting
Oslo, Norway
Contact: Michael Bretthauer, MD PhD         
Principal Investigator: Michael Bretthauer, MD PhD         
Poland
Maria Sklodowska-Curie Memorial Cancer Centre Recruiting
Warsaw, Poland, 02-781
Contact: Jaroslaw Regula, MD PhD    48 606 906 992    jregula@coi.waw.pl   
Contact: Michal Kaminski, MD PhD    48 606 906 992    mfkaminski@coi.waw.pl   
Principal Investigator: Jaroslaw Regula, MD PhD         
Sub-Investigator: Michal Kaminski, MD PhD         
Sweden
Karolinska Institute Active, not recruiting
Stockholm, Sweden
Uppsala University Hospital Not yet recruiting
Uppsala, Sweden
Contact: Lars Pahlman, MD PhD         
Principal Investigator: Lars Pahlman, MD PhD         
Sponsors and Collaborators
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
Investigators
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
  More Information

No publications provided by Norwegian Department of Health and Social Affairs

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Geir Hoff, MD pHD and Michael Bretthauer MD PhD, The Cancer Registry of Norway
ClinicalTrials.gov Identifier: NCT00883792     History of Changes
Other Study ID Numbers: NordICC
Study First Received: April 17, 2009
Last Updated: June 9, 2011
Health Authority: Norway: Regional review board
Poland: Ministry of Health
Netherlands: Medical Ethics Review Committee (METC)
Sweden: Swedish National Council on Medical Ethics
Iceland: Ministry of Health and Social Security

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 23, 2014