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NordICC The Northern-European Initiative on Colorectal Cancer


Phase 3
55 Years
64 Years
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

NordICC The Northern-European Initiative on Colorectal Cancer


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Comparison of the screening group vs. the control group in an intention-to-treat model after 15 years of follow-up with regard to CRC mortality and CRC incidence

Outcome Time Frame:

15 years after screening (interim analysis after 10 years)

Safety Issue:

No

Principal Investigator

Hans-Olov Adami, MD PhD

Investigator Role:

Study Director

Investigator Affiliation:

Harvard School of Public Health, Boston, USA

Authority:

Norway: Regional review board

Study ID:

NordICC

NCT ID:

NCT00883792

Start Date:

May 2009

Completion Date:

July 2036

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Harvard School of Public HealthBoston, Massachusetts  02115