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NCT00883792 · ClinicalTrials.gov registry record · Phase 3
The Northern-European Initiative on Colorectal Cancer
A Phase 3 study of Colorectal Cancer, sponsored by Oslo University Hospital.
- Active
- Registry status
- Phase 3
- Development phase
- 95,000
- Enrollment target
- 7
- Study locations
NCT00883792 is a Phase 3 study of Colorectal Cancer that is active but no longer recruiting, run by Oslo University Hospital. The registered enrollment target is 95,000 participants, above the 1,254-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (7476% higher). The trial reports 7 study locations across 3 states.
The verdict
NCT00883792, a Phase 3 study of Colorectal Cancer, is active but no longer recruiting, sponsored by Oslo University Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 95,000 participants
- Enrollment target
- 7
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 95,000 participants |
| Start Date | 2009-05 |
| Est. Completion | 2036-07 |
| Phase | Phase 3 |
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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, categorized as Phase 3. The registered enrollment target is 95,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,254-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (7476% higher). The listed sponsor is Oslo University Hospital, which has 3 total studies on file at ClinicalTrials.gov.
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.
NCT00883792 reports 7 study locations spanning 3 distinct geographic areas - top geographies include Other, Massachusetts, New York.
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.
What interventions are being tested in trial NCT00883792?
The interventions under investigation include: Colonoscopy (PROCEDURE).
Who is sponsoring clinical trial NCT00883792?
This trial is sponsored by Oslo University Hospital, which has 3 total clinical trials registered on ClinicalTrials.gov.
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.
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Related
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