The Northern-European Initiative on Colorectal Cancer

NCT ID: NCT00883792

Last Updated: 2017-06-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 95000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2036-07-31

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Colonoscopy

Intervention Type: PROCEDURE

Once-only colonoscopy screening

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Colonoscopy

Once-only colonoscopy screening

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maria Sklodowska-Curie National Research Institute of Oncology

OTHER

Sponsor Role: collaborator

Erasmus Medical Center

OTHER

Sponsor Role: collaborator

Landspitali University Hospital

OTHER

Sponsor Role: collaborator

Uppsala University Hospital

OTHER

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Michael Bretthauer

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hans-Olov Adami, MD PhD

Role: STUDY_DIRECTOR

Harvard School of Public Health, Boston, USA

Michael Bretthauer, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Michal Filip Kaminski, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Marie Cure Sklodowska Cancer Center

Locations

Harvard School of Public Health

Boston, Massachusetts, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Landspitali University Hospital

Reykjavik, , Iceland

Erasmus University Medical Center

Rotterdam, , Netherlands

Oslo University Hospital

Oslo, , Norway

Maria Sklodowska-Curie Memorial Cancer Centre

Warsaw, , Poland

Karolinska Institute

Stockholm, , Sweden

Countries

United States; Iceland; Netherlands; Norway; Poland; Sweden

References

Bretthauer M, Loberg M, Wieszczy P, Kalager M, Emilsson L, Garborg K, Rupinski M, Dekker E, Spaander M, Bugajski M, Holme O, Zauber AG, Pilonis ND, Mroz A, Kuipers EJ, Shi J, Hernan MA, Adami HO, Regula J, Hoff G, Kaminski MF; NordICC Study Group. Effect of Colonoscopy Screening on Risks of Colorectal Cancer and Related Death. N Engl J Med. 2022 Oct 27;387(17):1547-1556. doi: 10.1056/NEJMoa2208375. Epub 2022 Oct 9.

Reference Type: DERIVED

PMID: 36214590 (View on PubMed)

Shaukat A, Kahi CJ, Burke CA, Rabeneck L, Sauer BG, Rex DK. ACG Clinical Guidelines: Colorectal Cancer Screening 2021. Am J Gastroenterol. 2021 Mar 1;116(3):458-479. doi: 10.14309/ajg.0000000000001122.

Reference Type: DERIVED

PMID: 33657038 (View on PubMed)

Bretthauer M, Kaminski MF, Loberg M, Zauber AG, Regula J, Kuipers EJ, Hernan MA, McFadden E, Sunde A, Kalager M, Dekker E, Lansdorp-Vogelaar I, Garborg K, Rupinski M, Spaander MC, Bugajski M, Hoie O, Stefansson T, Hoff G, Adami HO; Nordic-European Initiative on Colorectal Cancer (NordICC) Study Group. Population-Based Colonoscopy Screening for Colorectal Cancer: A Randomized Clinical Trial. JAMA Intern Med. 2016 Jul 1;176(7):894-902. doi: 10.1001/jamainternmed.2016.0960.

Reference Type: DERIVED

PMID: 27214731 (View on PubMed)

Pisera M, Kaminski MF, Kraszewska E, Rupinski M, Regula J. Reinvitation to screening colonoscopy: a randomized-controlled trial of reminding letter and invitation to educational meeting on attendance in nonresponders to initial invitation to screening colonoscopy (REINVITE). Eur J Gastroenterol Hepatol. 2016 May;28(5):538-42. doi: 10.1097/MEG.0000000000000578.

Reference Type: DERIVED

PMID: 26967693 (View on PubMed)

Kaminski MF, Bretthauer M, Zauber AG, Kuipers EJ, Adami HO, van Ballegooijen M, Regula J, van Leerdam M, Stefansson T, Pahlman L, Dekker E, Hernan MA, Garborg K, Hoff G. The NordICC Study: rationale and design of a randomized trial on colonoscopy screening for colorectal cancer. Endoscopy. 2012 Jul;44(7):695-702. doi: 10.1055/s-0032-1306895. Epub 2012 Jun 21.

Reference Type: DERIVED

PMID: 22723185 (View on PubMed)

Other Identifiers

NordICC

Identifier Type: -

Identifier Source: org_study_id