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Trial record 2 of 11 for:    bretthauer

The Northern-European Initiative on Colorectal Cancer (NordICC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00883792
Recruitment Status : Active, not recruiting
First Posted : April 20, 2009
Last Update Posted : June 19, 2017
Sponsor:
Collaborators:
Maria Sklodowska-Curie Institute - Oncology Center
Erasmus Medical Center
Landspitali University Hospital
Uppsala University Hospital
Karolinska Institutet
Memorial Sloan Kettering Cancer Center
Harvard School of Public Health
Information provided by (Responsible Party):
Michael Bretthauer, University of Oslo

Tracking Information
First Submitted Date  ICMJE April 17, 2009
First Posted Date  ICMJE April 20, 2009
Last Update Posted Date June 19, 2017
Study Start Date  ICMJE May 2009
Estimated Primary Completion Date June 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2010)
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) ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 17, 2009)
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) ]
Change History Complete list of historical versions of study NCT00883792 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2010)
  • 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) ]
  • Mortality from all causes [ Time Frame: 15 years after screening (interim analysis after 10 years) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2009)
  • 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) ]
  • Mortality from all causes [ Time Frame: 15 years after screening (interim analyses after 5 and 10 years) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Northern-European Initiative on Colorectal Cancer
Official Title  ICMJE NordICC The Northern-European Initiative on Colorectal Cancer
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE Procedure: Colonoscopy
Once-only colonoscopy screening
Study Arms  ICMJE
  • 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.

Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 16, 2017)
95000
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2009)
66000
Estimated Study Completion Date  ICMJE July 2036
Estimated Primary Completion Date June 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iceland,   Netherlands,   Norway,   Poland,   Sweden,   United States
Removed Location Countries Latvia
 
Administrative Information
NCT Number  ICMJE NCT00883792
Other Study ID Numbers  ICMJE NordICC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Bretthauer, University of Oslo
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE
  • Maria Sklodowska-Curie Institute - Oncology Center
  • Erasmus Medical Center
  • Landspitali University Hospital
  • Uppsala University Hospital
  • Karolinska Institutet
  • Memorial Sloan Kettering Cancer Center
  • Harvard School of Public Health
Investigators  ICMJE
Study Director: Hans-Olov Adami, MD PhD Harvard School of Public Health, Boston, USA
Principal Investigator: Michael Bretthauer, MD PhD Oslo University Hospital
Principal Investigator: Michal Filip Kaminski, MD PhD Marie Cure Sklodowska Cancer Center
PRS Account Oslo University Hospital
Verification Date June 2017

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