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Trial record 1 of 1 for:    NCT00119912
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NORCCAP: Norwegian Colorectal Cancer Prevention Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00119912
Recruitment Status : Active, not recruiting
First Posted : July 14, 2005
Last Update Posted : September 9, 2019
Sponsor:
Collaborator:
Norwegian Cancer Society
Information provided by (Responsible Party):
Norwegian Department of Health and Social Affairs

Tracking Information
First Submitted Date  ICMJE July 6, 2005
First Posted Date  ICMJE July 14, 2005
Last Update Posted Date September 9, 2019
Study Start Date  ICMJE January 1999
Estimated Primary Completion Date December 2036   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: July 6, 2005)
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2005)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NORCCAP: Norwegian Colorectal Cancer Prevention Trial
Official Title  ICMJE Norwegian Colorectal Cancer Prevention Trial
Brief Summary 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.
Detailed Description

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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Colorectal Cancer
  • Adenoma
Intervention  ICMJE
  • Procedure: A 1 Intervention arm Flex Sig
    Screening by flexible sigmoidoscopy
  • 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
Study Arms  ICMJE
  • 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..
    Intervention: Procedure: A 1 Intervention arm Flex Sig
  • 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.
    Intervention: Procedure: A 2 Intervention arm Flex Sig + iFOBT
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 6, 2005)
100000
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2036
Estimated Primary Completion Date December 2036   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00119912
Other Study ID Numbers  ICMJE NORCCAP-1
Shdir 97/08614 ( Other Identifier: Norwegian Department of Health )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Norwegian Department of Health and Social Affairs
Study Sponsor  ICMJE Norwegian Department of Health and Social Affairs
Collaborators  ICMJE Norwegian Cancer Society
Investigators  ICMJE
Study Chair: Giske Ursin, M.D. Institute of Population-based Cancer Research
PRS Account Norwegian Department of Health and Social Affairs
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP