NORCCAP: Norwegian Colorectal Cancer Prevention Trial - Full Text View

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 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Norwegian Colorectal Cancer Prevention Trial

Resource links provided by NLM:

MedlinePlus related topics: Benign Tumors Bowel Movement Cancer Colorectal Cancer

U.S. FDA Resources

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 (published),2012,2017 ] [ Designated as safety issue: Yes ]

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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: Yes ]

Enrollment:	100000
Study Start Date:	January 1999
Estimated Study Completion Date:	January 2017
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A 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
No Intervention: B "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 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:

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

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

Additional Information:

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

Publications:

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.

Hoff G, Grotmol T, Skovlund E, Bretthauer M; Norwegian Colorectal Cancer Prevention Study Group. Risk of colorectal cancer seven years after flexible sigmoidoscopy screening: randomised controlled trial. BMJ. 2009 May 29;338:b1846.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Riedel BM, Molloy AM, Meyer K, Fredriksen A, Ulvik A, Schneede J, Nexø E, Hoff G, Ueland PM. Transcobalamin polymorphism 67A->G, but Not 776C->G, affects serum holotranscobalamin in a cohort of healthy middle-aged men and women. J Nutr. 2011 Oct;141(10):1784-90. Epub 2011 Aug 24.

Hoff G, Bretthauer M. Appointments timed in proximity to annual milestones and compliance with screening: randomised controlled trial. BMJ. 2008 Dec 17;337:a2794.

Responsible Party:	Norwegian Department of Health and Social Affairs
ClinicalTrials.gov Identifier:	NCT00119912 History of Changes
Other Study ID Numbers:	NORCCAP-1, Shdir 97/08614
Study First Received:	July 6, 2005
Last Updated:	January 7, 2013
Health Authority:	Norway: Directorate of Health

Keywords provided by Norwegian Department of Health and Social Affairs:

screening
flexible sigmoidoscopy
fecal occult blood

cancer
colon
rectum

Additional relevant MeSH terms:

Adenoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms

Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 16, 2013