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, Inhaltsverzeichnis

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

Autor*innen

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

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.

Volltext

Referenzen

References
1 Ferlay J, Parkin DM, Steliarova-Foucher E. Estimates of cancer incidence and mortality in Europe in 2008. Eur J Cancer 2010; 46: 765-781
2 Pox C, Schmiegel W, Classen M. Current status of screening colonoscopy in Europe and in the United States. Endoscopy 2007; 39: 168-173
3 Butruk E, Regula J, Polkowski M et al. National colorectal cancer screening programme in Poland. Endoscopy 2002; 34: 939-940
4 Rex DK, Johnson DA, Anderson JC et al. American College of Gastroenterology Guidelines for Colorectal Cancer Screening 2008. Am J Gastroenterol 2009; 104: 739-750
5 Mandel JS, Bond JH, Church TR et al. Reducing mortality from colorectal cancer by screening for fecal occult blood. N Engl J Med 1993; 328: 1365-1371 . [Erratum, N Engl J Med 1993; 329: 672.]
6 Kronborg O, Fenger C, Olsen J et al. Randomised study of screening for colorectal cancer with faecal-occult-blood test. Lancet 1996; 348: 1467-1471
7 Hardcastle JD, Chamberlain JO, Robinson MHE et al. Randomised controlled trial of faecal-occult-blood screening for colorectal cancer. Lancet 1996; 348: 1472-1477
8 Winawer SJ, Zauber AG, Ho MN. The National Polyp Study Workgroup et al. Prevention of colorectal cancer by colonoscopic polypectomy. N Engl J Med 1993; 329: 1977-1981
9 Atkin WS, Cuzik J, Northover JMA et al. Prevention of colorectal cancer by once-only sigmoidoscopy. Lancet 1993; 341: 736-740
10 Thiis-Evensen E, Hoff G, Sauar J et al. Population-based surveillance by colonoscopy: Effect on the incidence of colorectal cancer. Telemark Polyp Study I. Scand J Gastroenterol 1999; 34: 414-420
11 Selby JV, Friedman GD, Quesenberry CP Jr et al. A case–control study of screening sigmoidoscopy and mortality from colorectal cancer. N Engl J Med 1992; 326: 653-657
12 Atkin WS, Edwards R, Kralj-Hans I et al. Once-only flexible sigmoidoscopy screening in prevention of colorectal cancer: a multicenter randomized trial. Lancet 2010; 375: 1624-1633
13 Rex DK, Rahmani EY, Haseman JH et al. Relative sensitivity of colonoscopy and barium enema for detection of colorectal cancer in clinical practice. Gastroenterology 1997; 112: 17-23
14 Pickhardt PJ, Nugent PA, Mysliwiec PA et al. Location of adenomas missed by optical colonoscopy. Ann Intern Med 2004; 141: 352-359
15 Kaminski MF, Regula J, Kraszewska E et al. Quality indicators for colonoscopy and the risk of interval cancer. N Engl J Med 2010; 362: 1795-1803
16 McCallion K, Mitchell RM, Wilson RH et al. Flexible sigmoidoscopy and the changing distribution of colorectal cancer: implications for screening. Gut 2001; 48: 522-525
17 Rabeneck L, Davila JA, El-Serag HB. Is there a true “shift” to the right colon in the incidence of colorectal cancer?. Am J Gastroenterol 2003; 98: 1400-1409
18 Schoenfeld P, Cash B, Flood A et al. Colonoscopic screening of average-risk women for colorectal neoplasia. N Engl J Med 2005; 352: 2061-2068
19 Morikawa T, Kato J, Yamaji Y et al. A comparison of the immunochemical fecal occult blood test and total colonoscopy in the asymptomatic population. Gastroenterology 2005; 129: 422-428
20 Guittet L, Bouvier V, Mariotte N et al. Comparison of a guaiac based and an immunochemical faecal occult blood test in screening for colorectal cancer in a general average risk population. Gut 2007; 56: 210-214
21 Hol L, Van Leerdam ME, Van Ballegooijen M et al. Screening for colorectal cancer; randomized trial comparing guaiac-based and immunochemical faecal occult blood testing and flexible sigmoidoscopy. Gut 2009; 59: 62-68
22 Levin B, Lieberman D, McFarland B et al. Screening and surveillance for the early detection of colorectal cancer and adenomatous polyps, 2008: A joint guideline from the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology. Gastroenterology 2008; 134: 1570-1595
23 Regula J, Rupinski M, Kraszewska E et al. Colonoscopy in colorectal-cancer screening for detection of advanced neoplasia. N Engl J Med 2006; 355: 1863-1872
24 Mandel JS, Church TR, Bond JH et al. The effect of fecal occult-blood screening on the incidence of colorectal cancer. N Engl J Med 2000; 343: 1603-1607
25 Winawer SJ, Zauber AG, Ho MN. The National Polyp Study Workgroup et al. Prevention of colorectal cancer by colonoscopic polypectomy. N Engl J Med 1993; 329: 1977-1981
26 Zauber AG, Winawer SJ, O’Brien MJ et al. Significant long term reduction in colorectal cancer mortality with colonoscopic polypectomy: findings of the National Polyp Study. Gastrointest Endosc 2007; 65: AB268
27 Citarda F, Tomaselli G, Capocaccia R. The Italian Multicenter Study Group et al. Efficacy in standard clinical practice of colonoscopic polypectomy in reducing colorectal cancer incidence. Gut 2001; 48: 812-815
28 Baxter NN, Goldwasser MA, Paszat LF et al. Association of colonoscopy and death from colorectal cancer: a population-based, case–control study. Ann Intern Med 2008; 150: 1-8
29 Brenner H, Chang-Claude J, Seiler CM et al. Protection from colorectal cancer after colonoscopy: a population-based study, case–control study. Ann Intern Med 2011; 154: 22-30
30 Inadomi J, Kuhn L, Vijan S et al. Adherence to competing colorectal cancer screening strategies. Am J Gastroenterol 2005; 100: S387-S388
31 Hoff G, Grotmol T, Skovlund E et al. Risk of colorectal cancer seven years after flexible sigmoidoscopy screening: randomized controlled trial. BMJ 2009;
32 Atkin WS, Hart A, Edwards R et al. Uptake, yield of neoplasia, and adverse effects of flexible sigmoidoscopy screening. Gut 1998; 42: 560-565
33 Segnan N, Senore C, Andreoni B et al. Comparing attendance and detection rate of colonoscopy with sigmoidoscopy and FIT for colorectal cancer screening. Gastroenterology 2007; 132: 2304-2312
34 Kahi CJ, Imperiale TF, Juliar BE et al. Effect of screening colonoscopy on colorectal cancer incidence and mortality. Clin Gastroenterol Hepatol 2009; 7: 770-775
35 Rabeneck L, Paszat LF, Hilsden RJ et al. Bleeding and perforation after outpatient colonoscopy and their risk factors in usual clinical practice. Gastroenterology 2008; 135: 1899-1906
36 Levin TR, Zhao W, Conell C et al. Complications of colonoscopy in an integrated health care delivery system. Ann Intern Med 2006; 145: 880-886
37 Stemmermann GN. Cancer of the colon and rectum discovered at autopsy in Hawaiian Japanese. Cancer 1966; 11: 1567-1572
38 Larsen IK, Grotmol T, Almendingen K et al. Impact of colorectal cancer screening on future lifestyle choices: a three-year randomized controlled trial. Clin Gastroenterol Hepatol 2007; 5: 477-483
39 Ahlquist DA. Fecal occult blood testing for colorectal cancer. Can we afford to do this?. Gastroenterol Clin North Am 1997; 26: 41-55
40 Moayyedi P, Achkar E. Does fecal occult blood testing really reduce mortality? A reanalysis of systematic review data. Am J Gastroenterol 2006; 101: 380-384
41 Segnan N, Patnick J, von Karsa L eds. European guidelines for quality assurance in colorectal cancer screening and diagnosis. Luxembourg: European Union; 2010. ISBN: 978-92-79-16574-0
42 Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Chron Dis 1967; 20: 637-648
43 McMahon AD. Study control, violators, inclusion criteria and defining explanatory and pragmatic trials. Stat Med 2002; 21: 1365-1376
44 Harewood GC, Wiersema MJ, Melton LJ 3rd. A prospective, controlled assessment of factors influencing acceptance of screening colonoscopy. Am J Gastroenterol 2002; 97: 3186-3194
45 Hoff G, Bretthauer M. Appointments timed in proximity to annual milestones and compliance with screening: randomized controlled trial. BMJ 2008; 337: a2794
46 Bretthauer M, Lynge AB, Thiis-Evensen E et al. Carbon dioxide insufflation in colonoscopy: safe and effective in sedated patients. Endoscopy 2005; 37: 706-709
47 Hamilton SR, Aaltonen LA eds. World Health Organization classification of tumours. Pathology and genetics of tumors of the digestive system. Lyon: IARC Press; 2000: 104-119
48 Hoff G, Ottestad PM, Skafløtten SR et al. Quality assurance as an integrated part of the electronic medical record – a prototype applied for colonoscopy. Scand J Gastroenterol 2009; 4: 1-7
49 Naslund U, Grip L, Fischer-Hansen J et al. The impact of an end-point committee in a large multicentre, randomized, placebo-controlled clinical trial. Eur Heart J 1999; 20: 771-777
50 ICD-10 International statistical classification of diseases and related health problems. 10th revision. 2. Geneva: World Health Organization; 2004
51 Lisi D, Hassan C, Crespi M. AMOD Study Group. Participation in colorectal cancer screening with FOBT and colonoscopy: an Italian, multicentre, randomized population study. Dig Liver Dis 2009; 42: 371-376
52 Cuzick J, Edwards R, Segnan N. Adjusting for non-compliance and contamination in randomized clinical trials. Stat Med 1997; 16: 1017-1029
53 O’Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics 1979; 35: 549-556
54 Robertson DJ, Greenberg ER, Beach M et al. Colorectal cancer in patients under close colonoscopic surveillance. Gastroenterology 2005; 129: 34-41
55 Jorgensen OD, Kronborg O, Fenger C. The Funen Adenoma Follow-up Study. Incidence and death from colorectal carcinoma in an adenoma surveillance program. Scand J Gastroenterol 1993; 28: 869-874
56 Hoff G, Bretthauer M, Huppertz-Haus G et al. The Norwegian Gastronet project: Continuous quality improvement of colonoscopy in 14 Norwegian centres. Scand J Gastroenterol 2006; 41: 481-487