The purpose of this study is to see if screening with flexible sigmoidoscopy (a flexible viewing tube) may reduce large bowel cancer and cancer deaths. The researchers also want to see if the addition of screening for occult blood in stools may contribute further to this aim. Additionally, the researchers also want to see to which extent (and in which direction) the study may influence overall endoscopic activity in the general population in the screening area and in areas where controlled screening is not established.

Condition	Intervention	Phase
Colorectal Cancer Adenoma	Procedure: Flexible sigmoidoscopy screening  Procedure: Fecal Occult Blood Test (FOBT) screening	Phase II Phase III

Further Study Details: 

Primary Outcomes: 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.; 2. 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. Forst evaluation after 5 years.; 3. 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.First evaluation after 5 years.
Secondary Outcomes: 1. Determine the prevalence of known types familial CRC in a general population and try to define other groups with intermediate increased risk. Results "in press" 2005.; 2. Clarify possible psychosocial effects of endoscopic screening and how it may influence lifestyle and lifestyle related morbidity and overall mortality. Evaluation in 2005.
Expected Total Enrollment:  100000

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 aims are as follows: 1. Evaluate the effect on CRC mortality and morbidity by screen detection of CRC and removal of precursor lesions (polypectomy of adenomatous polyps) 2. 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 3. 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

Secondary aims: 1. Determine the prevalence of known types familial CRC in a general population and try to define other groups with intermediate increased risk 2. 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).

Ages Eligible for Study:  50 Years   -   64 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

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

Norway
      Institute of Population-based Cancer Research, Oslo,  0310,  Norway

Study chairs or principal investigators

Frøydis Langmark, M.D.,  Study Chair,  Institute of Population-based Cancer Research   

Study ID Numbers:  NORCCAP-1; Shdir 97/08614
Last Updated:  July 18, 2005
Record first received:  July 14, 2005
ClinicalTrials.gov Identifier:  NCT00119912
Health Authority: Norway: Directorate for Health and Social Affairs
ClinicalTrials.gov processed this record on 2005-08-02