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NORCCAP: Norwegian Colorectal Cancer Prevention Trial
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Norwegian Department of Health and Social Affairs
Norwegian Cancer Society
Information provided by: Norwegian Department of Health and Social Affairs
ClinicalTrials.gov Identifier: NCT00119912
  Purpose

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
Procedure: Fecal Occult Blood Test (FOBT) screening
Phase II
Phase III

MedlinePlus related topics: Cancer Colorectal Cancer Endoscopy
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Norwegian Colorectal Cancer Prevention Trial

Further study details as provided by Norwegian Department of Health and Social Affairs:

Primary Outcome Measures:
  • 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 2007,2012,2017 ]
  • 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. First evaluation after 5 years. [ Time Frame: Evaluations in 2007, 2012, 2017 ]
  • 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. [ Time Frame: Evaluation i 2012 ]

Secondary Outcome Measures:
  • 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) ]
  • 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) ]

Enrollment: 100000
Study Start Date: January 1999
Estimated Study Completion Date: January 2017
Arms Assigned Interventions
A: Active Comparator
Randomised from the population registry, age 50-64 years and invited for Flexible Sigmoidoscopy screening. Half of invitees are additionally invited to provide a stool sample for fecal occult blood testing.
Procedure: Flexible sigmoidoscopy Procedure: Fecal Occult Blood Test (FOBT) screening
In addition to Flexible Sigmoidoscopy, half of arm A (randomised 1:1) is invited to provide stool samples for FOBT
B: No Intervention
"No screening group" randomised from population age 50-64 years

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 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).

  Eligibility

Ages Eligible for Study:   50 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00119912

Locations
Norway
Institute of Population-based Cancer Research
Oslo, Norway, 0310
Sponsors and Collaborators
Norwegian Department of Health and Social Affairs
Norwegian Cancer Society
Investigators
Study Chair: Frøydis Langmark, M.D. Institute of Population-based Cancer Research
  More Information

Website for the Norwegian Cancer Registry  This link exits the ClinicalTrials.gov site

Publications of Results:
Larsen IK, Grotmol T, Almendingen K, Hoff G. Impact of colorectal cancer screening on future lifestyle choices: a three-year randomized controlled trial. Clin Gastroenterol Hepatol. 2007 Apr;5(4):477-83. Epub 2007 Mar 23.
Larsen IK, Grotmol T, Almendingen K, Hoff G. Lifestyle as a predictor for colonic neoplasia in asymptomatic individuals. BMC Gastroenterol. 2006 Jan 13;6:5.
Larsen IK, Grotmol T, Almendingen K, Hoff G. Lifestyle characteristics among participants in a Norwegian colorectal cancer screening trial. Eur J Cancer Prev. 2006 Feb;15(1):10-9.
Stormorken AT, Hoff G, Norstein J, Bowitz-Lothe IM, Hanslien E, Grindedal E, Moller P. Estimated prevalence of hereditary cancers and the need for surveillance in a Norwegian county, Telemark. Scand J Gastroenterol. 2006 Jan;41(1):71-9.
Gondal G, Grotmol T, Hofstad B, Bretthauer M, Eide TJ, Hoff G. Biopsy of colorectal polyps is not adequate for grading of neoplasia. Endoscopy. 2005 Dec;37(12):1193-7.
Gondal G, Grotmol T, Hofstad B, Bretthauer M, Eide TJ, Hoff G. Lifestyle-related risk factors and chemoprevention for colorectal neoplasia: experience from the large-scale NORCCAP screening trial. Eur J Cancer Prev. 2005 Aug;14(4):373-9.
Skovlund E, Bretthauer M, Grotmol T, Larsen IK, Hoff G. Sensitivity of pain rating scales in an endoscopy trial. Clin J Pain. 2005 Jul-Aug;21(4):292-6.
Hoff G, Grotmol T, Thiis-Evensen E, Bretthauer M, Gondal G, Vatn MH. Testing for faecal calprotectin (PhiCal) in the Norwegian Colorectal Cancer Prevention trial on flexible sigmoidoscopy screening: comparison with an immunochemical test for occult blood (FlexSure OBT). Gut. 2004 Sep;53(9):1329-33.
Bretthauer M, Skovlund E, Grotmol T, Thiis-Evensen E, Gondal G, Huppertz-Hauss G, Efskind P, Hofstad B, Thorp Holmsen S, Eide TJ, Hoff G. Inter-endoscopist variation in polyp and neoplasia pick-up rates in flexible sigmoidoscopy screening for colorectal cancer. Scand J Gastroenterol. 2003 Dec;38(12):1268-74.
Bretthauer M, Hoff GS, Thiis-Evensen E, Huppertz-Hauss G, Skovlund E. Air and carbon dioxide volumes insufflated during colonoscopy. Gastrointest Endosc. 2003 Aug;58(2):203-6.
Gondal G, Grotmol T, Hofstad B, Bretthauer M, Eide TJ, Hoff G. The Norwegian Colorectal Cancer Prevention (NORCCAP) screening study: baseline findings and implementations for clinical work-up in age groups 50-64 years. Scand J Gastroenterol. 2003 Jun;38(6):635-42.
Bretthauer M, Jorgensen A, Kristiansen BE, Hofstad B, Hoff G. Quality control in colorectal cancer screening: systematic microbiological investigation of endoscopes used in the NORCCAP (Norwegian Colorectal Cancer Prevention) trial. BMC Gastroenterol. 2003 Jun 13;3:15.
Bretthauer M, Hoff G. The use of CO2 in colonoscopy. Gastrointest Endosc. 2003 Mar;57(3):436-7; author reply 437-8. No abstract available.
Gondal G, Grotmol T, Hofstad B, Bretthauer M, Eide TJ, Hoff G. Grading of distal colorectal adenomas as predictors for proximal colonic neoplasia and choice of endoscope in population screening: experience from the Norwegian Colorectal Cancer Prevention study (NORCCAP). Gut. 2003 Mar;52(3):398-403.
Bretthauer M, Hoff G, Thiis-Evensen E, Grotmol T, Holmsen ST, Moritz V, Skovlund E. Carbon dioxide insufflation reduces discomfort due to flexible sigmoidoscopy in colorectal cancer screening. Scand J Gastroenterol. 2002 Sep;37(9):1103-7.
Bretthauer M, Hoff G, Thiis-Evensen E, Grotmol T, Larsen IK, Kjellevold O, Skovlund E. Use of a disposable sheath system for flexible sigmoidoscopy in decentralized colorectal cancer screening. Endoscopy. 2002 Oct;34(10):814-8.
Larsen IK, Grotmol T, Bretthauer M, Gondal G, Huppertz-Hauss G, Hofstad B, Efskind P, Jorgensen A, Hoff G. Continuous evaluation of patient satisfaction in endoscopy centres. Scand J Gastroenterol. 2002 Jul;37(7):850-5.
Bretthauer M, Gondal G, Larsen K, Carlsen E, Eide TJ, Grotmol T, Skovlund E, Tveit KM, Vatn MH, Hoff G. Design, organization and management of a controlled population screening study for detection of colorectal neoplasia: attendance rates in the NORCCAP study (Norwegian Colorectal Cancer Prevention). Scand J Gastroenterol. 2002 May;37(5):568-73.
Bretthauer M, Thiis-Evensen E, Huppertz-Hauss G, Gisselsson L, Grotmol T, Skovlund E, Hoff G. NORCCAP (Norwegian colorectal cancer prevention): a randomised trial to assess the safety and efficacy of carbon dioxide versus air insufflation in colonoscopy. Gut. 2002 May;50(5):604-7.

Publications indexed to this study:
Study ID Numbers: NORCCAP-1, Shdir 97/08614
Study First Received: July 6, 2005
Last Updated: December 4, 2008
ClinicalTrials.gov Identifier: NCT00119912  
Health Authority: Norway: Directorate for Health and Social Affairs

Keywords provided by Norwegian Department of Health and Social Affairs:
screening
flexible sigmoidoscopy
fecal occult blood
cancer
colon
rectum

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Adenoma
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009