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Clinical Trials (PDQ®)

The Northern-European Initiative on Colorectal Cancer

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIScreeningActive55 to 64OtherNordICC
NCT00883792

Trial Description

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 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)

Trial Contact Information

Trial Lead Organizations/Sponsors

Royal Norwegian Ministry of Health and Care Services

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw

Daniel Den Hoed Cancer Center at Erasmus Medical Center

Landspitalinn University Hospital

Uppsala University Hospital

Karolinska University Hospital - Huddinge

Latvian Cancer Center

Memorial Sloan-Kettering Cancer Center

Harvard School of Public Health

Hans-Olov Adami, MD PhDStudy Director

Michael Bretthauer, MD PhDPrincipal Investigator

Geir Hoff, MD PhDStudy Chair

Michael Bretthauer, MD PhDPh: +4790132480
  Email: michael.bretthauer@rikshospitalet.no

Trial Sites

Norway
  Oslo
 Cancer Registry of Norway
 Michael Bretthauer, MD PhD
 Michael Bretthauer, MD PhDPrincipal Investigator
Poland
  Warsaw
 Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
 Jaroslaw Regula, MD PhD Ph: 48 606 906 992
  Email: jregula@coi.waw.pl
 Michal Kaminski, MD PhD Ph: 48 606 906 992
  Email: mfkaminski@coi.waw.pl
 Jaroslaw Regula, MD PhDPrincipal Investigator
 Michal Kaminski, MD PhDSub-Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00883792
ClinicalTrials.gov processed this data on April 29, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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