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ACTIVE NOT RECRUITING Phase 3

The Northern-European Initiative on Colorectal Cancer

NCT00883792 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • PROCEDURE Colonoscopy

Study Locations (7)

Other

  • Landspitali University Hospital — Reykjavik
  • Erasmus University Medical Center — Rotterdam
  • Oslo University Hospital — Oslo
  • Maria Sklodowska-Curie Memorial Cancer Centre — Warsaw
  • Karolinska Institute — Stockholm

Massachusetts

  • Harvard School of Public Health — Boston

New York

  • Memorial Sloan-Kettering Cancer Center — New York

Trial Details

FieldValue
Enrollment Target 95,000 participants
Start Date 2009-05
Est. Completion 2036-07
Phase Phase 3

Sponsor

Oslo University Hospital

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00883792

The ClinicalTrials.gov registry entry for NCT00883792 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 95,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oslo University Hospital, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Colorectal Cancer appearing as the primary indexed condition, and to 1 intervention — of which Colonoscopy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00883792 reports 7 study locations spanning 3 distinct geographic areas — top geographies include Other, Massachusetts, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00883792 about?

NCT00883792 is a clinical study titled "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 e...

What is the current status of trial NCT00883792?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 95,000 participants. The study started on 2009-05. Estimated completion is 2036-07.

What conditions does trial NCT00883792 study?

This clinical trial studies the following conditions: Colorectal Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00883792?

The interventions under investigation include: Colonoscopy (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00883792?

This trial is sponsored by Oslo University Hospital, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00883792 being conducted?

This trial has 7 study locations across Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial