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Norwegian Colorectal Cancer Prevention Trial


Phase 2/Phase 3
50 Years
64 Years
Open (Enrolling)
Both
Colorectal Cancer, Adenoma

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Trial Information

Norwegian Colorectal Cancer Prevention Trial


Although flexible sigmoidoscopy (FS) as a screening tool has a much higher test sensitivity
than fecal occult blood tests (FOBT) for colorectal cancer and high-risk adenomas,
randomised trials with long-term follow-up are missing. The primary aim is to evaluate the
effect on CRC mortality and morbidity by screen detection of CRC and removal of precursor
lesions (polypectomy of adenomatous polyps)

Secondary aims:

1. Evaluation of cost/effectiveness of screening for CRC and significant, benign lesions
using flex-sig only compared to flex-sig in combination with faecal tests

2. To evaluate to which extent (and in which direction) the study may influence overall
endoscopic activity in the general population in the screening areas and in areas where
controlled screening is not established

3. Determine the prevalence of known types familial CRC in a general population and try to
define other groups with intermediate increased risk

4. Clarify possible psychosocial effects of endoscopic screening and how it may influence
lifestyle and lifestyle related morbidity and overall mortality

Population:

21,000 men and women, aged 50-64 years, living in the city of Oslo or the county of Telemark
are drawn by randomisation (approx. 1:5) from the population registry and invited to have a
flexible sigmoidoscopy examination. The control group constitutes 79,000 individuals. Those
invited for flexible sigmoidoscopy are further randomised (1:1) to bring or not to bring 3
successive stool samples for FOBT on attendance for FS.

Method:

This is a once-only screening concept with bowel cleansing being limited to a 240 ml
Sorbitol enema given on attendance. The threshold for work-up colonoscopy is low as a
positive screening test is defined as any polyp >9mm, any histologically verified adenoma
irrespective of size and a positive FOBT. The screening phase is limited to the period
January 1999- January 2002 and the first follow-up results will not be reported until all
entries have passed the 5-year mark (i.e. in early 2007).


Inclusion Criteria:



- Men and women

- Living in Oslo or Telemark

- Age 50-64 years

Exclusion Criteria:

- Patients with previous open colorectal surgery (resections, enterostomies)

- Individuals in need of long lasting attention and nursing services (somatic or
psychosocial reasons, mental retardation)

- On-going cytotoxic treatment or radiotherapy for malignant disease

- Severe chronic cardiac or lung disease (NYHA III-IV)

- Patients with heart valve replacement on life long anticoagulant therapy

- A coronary event during the last 3 months if having lead to hospitalisation

- Cerebrovascular accident during the last 3 months

- Resident abroad

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

1. Evaluate the effect on CRC mortality and morbidity by screen detection of CRC and removal of precursor lesions (polypectomy of adenomatous polyps).First evaluation after 5 years.

Outcome Time Frame:

Evaluations in 2007 (published),2012,2017

Safety Issue:

Yes

Principal Investigator

Fr√łydis Langmark, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Institute of Population-based Cancer Research

Authority:

Norway: Directorate of Health

Study ID:

NORCCAP-1

NCT ID:

NCT00119912

Start Date:

January 1999

Completion Date:

January 2017

Related Keywords:

  • Colorectal Cancer
  • Adenoma
  • screening
  • flexible sigmoidoscopy
  • fecal occult blood
  • cancer
  • colon
  • rectum
  • Adenoma
  • Colorectal Neoplasms

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