N/A
55 Years
64 Years
55 Years
64 Years
Not Enrolling
Both
Colorectal Cancer
Both
Colorectal Cancer
Trial Information
Inclusion Criteria
Inclusion criteria:
Individuals aged 55-64 years living in Warsaw area randomly drawn from Population Registry
and randomized to the screening arm of the NordICC trial.
Exclusion criteria:
- 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).
Exclusion criteria for colonoscopy:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Outcome Measure:
Participation rate
Outcome Description:
Percentage of attenders to screening colonoscopy.
Outcome Time Frame:
6 months from the date of sending invitation letter
Safety Issue:
No
Principal Investigator
Regula Jaroslaw, MD, PhD
Investigator Role:
Study Director
Investigator Affiliation:
Center of Oncology UInstitute and the Maria Sklodowska-Curie
Authority:
Poland: Ethics Committee
Study ID:
NR13002404_1
NCT ID:
NCT01505972
Start Date:
March 2011
Completion Date:
September 2011
Related Keywords:
- Colorectal Cancer
- screening colonoscopy
- attendance
- response
- colorectal cancer
- Colorectal Neoplasms
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