The NordICC Study: Rationale and design of a randomized trial on colonoscopy screening for colorectal cancer

M. F. Kaminski; M. Bretthauer; A. G. Zauber; E. J. Kuipers; H.-O. Adami; M. van Ballegooijen; J. Regula; M. van Leerdam; T. Stefansson; L. Påhlman; E. Dekker; M. A. Hernán; K. Garborg; G. Hoff; for the NordICC Study Group

doi:10.1055/s-0032-1306895

Endoscopy, Table of Contents

Endoscopy 2012; 44(07): 695-702
DOI: 10.1055/s-0032-1306895

Special report

The NordICC Study: Rationale and design of a randomized trial on colonoscopy screening for colorectal cancer

M. F. Kaminski

³Department of Gastroenterology and Hepatology, Medical Center for Postgraduate Education and the Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland

,

M. Bretthauer

¹Institute of Health and Society, Dep. of Health Management and Health Economy, University of Oslo, Oslo, Norway

²Dep. of Transplantation Medicine, Gastrointestinal Endoscopy Unit, Oslo, University Hospital, Oslo, Norway

,

A. G. Zauber

⁴Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, USA

,

E. J. Kuipers

⁵Departments of Gastroenterology and Hepatology, and Internal Medicine, Erasmus Medical Centre, Rotterdam, The Netherlands

,

H.-O. Adami

⁶Department of Epidemiology, Harvard School of Public Health, Boston, Massachusetts, USA

⁷Department of Medical Epidemiology and Biostatistics, Karolinska Institute, Stockholm, Sweden

,

M. van Ballegooijen

⁵Departments of Gastroenterology and Hepatology, and Internal Medicine, Erasmus Medical Centre, Rotterdam, The Netherlands

⁸Department of Public Health, Erasmus Medical Centre, Rotterdam, The Netherlands

,

J. Regula

³Department of Gastroenterology and Hepatology, Medical Center for Postgraduate Education and the Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland

,

M. van Leerdam

⁵Departments of Gastroenterology and Hepatology, and Internal Medicine, Erasmus Medical Centre, Rotterdam, The Netherlands

,

T. Stefansson

⁹Department of Surgery, Landspitali University Hospital, Reykjavik, Iceland

,

L. Påhlman

¹⁰Department of Surgical Sciences, Uppsala University Hospital, Uppsala, Sweden

,

E. Dekker

¹¹Department of Gastroenterology and Hepatology Academic, Medical Centre, Amsterdam, The Netherlands

,

M. A. Hernán

⁶Department of Epidemiology, Harvard School of Public Health, Boston, Massachusetts, USA

,

K. Garborg

¹²Department of Gastroenterology, Sørlandet Hospital, Kristiansand, Norway

,

G. Hoff

¹³Centre for Colorectal Cancer Screening, The Cancer Registry of Norway, Oslo University Hospital, Oslo, Norway

,

for the NordICC Study Group

› Author Affiliations

Abstract

Background and study aim: While colonoscopy screening is widely used in several European countries and the United States, there are no randomized trials to quantify its benefits. The Nordic-European Initiative on Colorectal Cancer (NordICC) is a multinational, randomized controlled trial aiming at investigating the effect of colonoscopy screening on colorectal cancer (CRC) incidence and mortality. This paper describes the rationale and design of the NordICC trial.

Study design: Men and women aged 55 to 64 years are drawn from the population registries in the participating countries and randomly assigned to either once-only colonoscopy screening with removal of all detected lesions, or no screening (standard of care in the trial regions). All individuals are followed for 15 years after inclusion using dedicated national registries. The primary end points of the trial are cumulative CRC-specific death and CRC incidence during 15 years of follow-up.

Power analysis: We hypothesize a 50 % CRC mortality-reducing efficacy of the colonoscopy intervention and predict 50 % compliance, yielding a 25 % mortality reduction among those invited to screening. For 90 % power and a two-sided alpha level of 0.05, using a 2:1 randomization, 45 600 individuals will be randomized to control, and 22 800 individuals to the colonoscopy group. Interim analyses of the effect of colonoscopy on CRC incidence and mortality will be performed at 10-year follow-up.

Conclusions: The aim of the NordICC trial is to quantify the effectiveness of population-based colonoscopy screening. This will allow development of evidence-based guidelines for CRC screening in the general population.

Trial registration: NCT 00883792.

Full Text

References

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