NORCCAP: Norwegian Colorectal Cancer Prevention Trial
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|ClinicalTrials.gov Identifier: NCT00119912|
Recruitment Status : Active, not recruiting
First Posted : July 14, 2005
Last Update Posted : April 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Adenoma||Procedure: A 1 Intervention arm Flex Sig Procedure: A 2 Intervention arm Flex Sig + iFOBT||Not Applicable|
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)
- 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
- 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
- Determine the prevalence of known types familial CRC in a general population and try to define other groups with intermediate increased risk
- Clarify possible psychosocial effects of endoscopic screening and how it may influence lifestyle and lifestyle related morbidity and overall mortality
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.
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Norwegian Colorectal Cancer Prevention Trial|
|Study Start Date :||January 1999|
|Estimated Primary Completion Date :||December 2036|
|Estimated Study Completion Date :||December 2036|
Active Comparator: A 1 Intervention arm Flex Sig
Randomised from the population registry, age 50-64 years and invited for Flexible Sigmoidoscopy (Flex Sig) screening. Half of invitees are additionally invited to provide a stool sample for fecal occult blood testing (Intervention arm A 2). They are drawn directly from the population registry without prior consent to be randomized - approved by Regional Ethics Committees of South-East Norway..
Procedure: A 1 Intervention arm Flex Sig
Screening by flexible sigmoidoscopy
No Intervention: B Control arm
"No screening group" randomised from population age 50-64 years. As for the active intervention arm, the control group was not informed about being randomized to 'no screening' since 'no screening' was the current usual care (and still is in 2015) in Norway - approved by Regional Ethics Committees of South-East Norway.
Active Comparator: A 2 Intervention arm Flex Sig + iFOBT
Randomised from the population registry, age 50-64 years and invited for Flexible Sigmoidoscopy (Flex Sig) screening plus an immunochemical test for fecal occult blood (iFOBT). As for arms A 1 and B, they are drawn directly from the population registry without prior consent to be randomized.
Procedure: A 2 Intervention arm Flex Sig + iFOBT
In addition to Flexible Sigmoidoscopy, half of arm A (randomised 1:1) is invited to provide stool samples for FOBT
- 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. [ Time Frame: Evaluations in 2007 (published),2012,2017 ]CRC incidence and mortality is followed
- 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. [ Time Frame: Evaluated in 2005 (published) ]Determine the prevalence of familial CRC in a general population sample
- 2. Clarify possible psychosocial effects of endoscopic screening and how it may influence lifestyle and lifestyle related morbidity and overall mortality. Evaluation in 2005. [ Time Frame: Evaluated in 2005 (published) ]Determine psychosocial effects of invitation to screening and of screening findings
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00119912
|Institute of Population-based Cancer Research|
|Oslo, Norway, 0310|
|Study Chair:||Frøydis Langmark, M.D.||Institute of Population-based Cancer Research|