NCT00119912

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100,000

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
129mo left

Started Jan 1999

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Jan 1999Dec 2036

Study Start

First participant enrolled

January 1, 1999

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 14, 2005

Completed
31.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2036

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2036

Last Updated

April 14, 2026

Status Verified

March 1, 2026

Enrollment Period

37.9 years

First QC Date

July 6, 2005

Last Update Submit

April 8, 2026

Conditions

Colorectal CancerAdenoma

Keywords

screeningflexible sigmoidoscopyfecal occult bloodcancercolonrectum

Outcome Measures

Primary Outcomes (1)

  • 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.

    CRC incidence and mortality is followed

    Evaluations in 2007 (published),2012,2017

Secondary Outcomes (2)

  • 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.

    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.

    Evaluated in 2005 (published)

Study Arms (3)

A 1 Intervention arm Flex Sig

ACTIVE COMPARATOR

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

B Control arm

NO INTERVENTION

"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.

A 2 Intervention arm Flex Sig + iFOBT

ACTIVE COMPARATOR

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

Interventions

A 1 Intervention arm Flex SigPROCEDURE

Screening by flexible sigmoidoscopy

A 1 Intervention arm Flex Sig
A 2 Intervention arm Flex Sig + iFOBTPROCEDURE

In addition to Flexible Sigmoidoscopy, half of arm A (randomised 1:1) is invited to provide stool samples for FOBT

A 2 Intervention arm Flex Sig + iFOBT

Eligibility Criteria

Age50 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women
  • Living in Oslo or Telemark
  • Age 50-64 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Population-based Cancer Research

Oslo, 0310, Norway

Location

Related Publications (29)

  • 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. doi: 10.1136/bmj.b1846.

    PMID: 19483252BACKGROUND

  • Holme O, Bretthauer M, Eide TJ, Loberg EM, Grzyb K, Loberg M, Kalager M, Adami HO, Kjellevold O, Hoff G. Long-term risk of colorectal cancer in individuals with serrated polyps. Gut. 2015 Jun;64(6):929-36. doi: 10.1136/gutjnl-2014-307793. Epub 2014 Nov 16.

    PMID: 25399542BACKGROUND

  • Berstad P, Loberg M, Larsen IK, Kalager M, Holme O, Botteri E, Bretthauer M, Hoff G. Long-term lifestyle changes after colorectal cancer screening: randomised controlled trial. Gut. 2015 Aug;64(8):1268-76. doi: 10.1136/gutjnl-2014-307376. Epub 2014 Sep 2.

    PMID: 25183203BACKGROUND

  • Holme O, Loberg M, Kalager M, Bretthauer M, Hernan MA, Aas E, Eide TJ, Skovlund E, Schneede J, Tveit KM, Hoff G. Effect of flexible sigmoidoscopy screening on colorectal cancer incidence and mortality: a randomized clinical trial. JAMA. 2014 Aug 13;312(6):606-15. doi: 10.1001/jama.2014.8266.

    PMID: 25117129BACKGROUND

  • 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. doi: 10.1016/j.cgh.2006.12.011. Epub 2007 Mar 23.

    PMID: 17363335RESULT

  • 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. doi: 10.1186/1471-230X-6-5.

    PMID: 16412216RESULT

  • 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. doi: 10.1097/01.cej.0000186636.27496.bb.

    PMID: 16374224RESULT

  • 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. doi: 10.1080/00365520510023891.

    PMID: 16373279RESULT

  • 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. doi: 10.1055/s-2005-921031.

    PMID: 16329016RESULT

  • 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. doi: 10.1097/00008469-200508000-00010.

    PMID: 16030428RESULT

  • 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. doi: 10.1097/01.ajp.0000110636.14355.3e.

    PMID: 15951645RESULT

  • 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. doi: 10.1136/gut.2004.039032.

    PMID: 15306594RESULT

  • 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. doi: 10.1080/00365520310006513.

    PMID: 14750648RESULT

  • 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. doi: 10.1067/mge.2003.340.

    PMID: 12872086RESULT

  • 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. doi: 10.1080/00365520310003002.

    PMID: 12825872RESULT

  • 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. doi: 10.1186/1471-230X-3-15.

    PMID: 12803654RESULT

  • Bretthauer M, Hoff G. The use of CO2 in colonoscopy. Gastrointest Endosc. 2003 Mar;57(3):436-7; author reply 437-8. doi: 10.1067/mge.2003.108. No abstract available.

    PMID: 12612542RESULT

  • 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. doi: 10.1136/gut.52.3.398.

    PMID: 12584223RESULT

  • 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. doi: 10.1080/003655202320378329.

    PMID: 12374237RESULT

  • 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. doi: 10.1055/s-2002-34273.

    PMID: 12244504RESULT

  • 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.

    PMID: 12190102RESULT

  • 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. doi: 10.1080/00365520252903125.

    PMID: 12059059RESULT

  • 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. doi: 10.1136/gut.50.5.604.

    PMID: 11950803RESULT

  • Jodal HC, Loberg M, Holme O, Adami HO, Bretthauer M, Emilsson L, Ransohoff DF, Hoff G, Kalager M. Mortality From Postscreening (Interval) Colorectal Cancers Is Comparable to That From Cancer in Unscreened Patients-A Randomized Sigmoidoscopy Trial. Gastroenterology. 2018 Dec;155(6):1787-1794.e3. doi: 10.1053/j.gastro.2018.08.035. Epub 2018 Aug 27.

    PMID: 30165051DERIVED

  • Holme O, Loberg M, Kalager M, Bretthauer M, Hernan MA, Aas E, Eide TJ, Skovlund E, Lekven J, Schneede J, Tveit KM, Vatn M, Ursin G, Hoff G; NORCCAP Study Groupdagger. Long-Term Effectiveness of Sigmoidoscopy Screening on Colorectal Cancer Incidence and Mortality in Women and Men: A Randomized Trial. Ann Intern Med. 2018 Jun 5;168(11):775-782. doi: 10.7326/M17-1441. Epub 2018 Apr 24.

    PMID: 29710125DERIVED

  • Berstad P, Botteri E, Larsen IK, Loberg M, Kalager M, Holme O, Bretthauer M, Hoff G. Lifestyle changes at middle age and mortality: a population-based prospective cohort study. J Epidemiol Community Health. 2017 Jan;71(1):59-66. doi: 10.1136/jech-2015-206760. Epub 2016 Jun 16.

    PMID: 27312250DERIVED

  • Swanson SA, Holme O, Loberg M, Kalager M, Bretthauer M, Hoff G, Aas E, Hernan MA. Bounding the per-protocol effect in randomized trials: an application to colorectal cancer screening. Trials. 2015 Nov 30;16:541. doi: 10.1186/s13063-015-1056-8.

    PMID: 26620120DERIVED

  • Riedel BM, Molloy AM, Meyer K, Fredriksen A, Ulvik A, Schneede J, Nexo 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. doi: 10.3945/jn.111.141960. Epub 2011 Aug 24.

    PMID: 21865561DERIVED

  • Hoff G, Bretthauer M. Appointments timed in proximity to annual milestones and compliance with screening: randomised controlled trial. BMJ. 2008 Dec 17;337:a2794. doi: 10.1136/bmj.a2794.

    PMID: 19091759DERIVED

Related Links

MeSH Terms

Conditions

Colorectal NeoplasmsAdenomaNeoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Giske Ursin, M.D.

    Norwegian Institute of Public Health

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2005

First Posted

July 14, 2005

Study Start

January 1, 1999

Primary Completion (Estimated)

December 1, 2036

Study Completion (Estimated)

December 1, 2036

Last Updated

April 14, 2026

Record last verified: 2026-03

Locations

NO(1)