NCT01538550

Brief Summary

The Norwegian government has funded a pilot study of a national colorectal cancer screening programme. This implies initiation of a screening pilot in the catchment area for two hospitals in Norway. The target population is average risk men and women at age 50-74 years. The programme is designed as a comparative effectiveness programme evaluating acceptance and test performance for two screening methods - fecal occult blood testing (FOBT) and flexible sigmoidoscopy (FS). This protocol describes the main methodological issues, necessary resources and the expected effects.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
140,000

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
104mo left

Started Mar 2012

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

2 active sites

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 Progress62%
Mar 2012Dec 2034

First Submitted

Initial submission to the registry

February 13, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 24, 2012

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
22.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2034

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2034

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

22.8 years

First QC Date

February 13, 2012

Last Update Submit

April 13, 2026

Conditions

Colorectal CancerColorectal Adenomas

Keywords

cancercolonrectumadenomascreeningiFOBTflexible sigmoidoscopyrandomized trial

Outcome Measures

Primary Outcomes (1)

  • colorectal cancer mortality

    colorectal cancer mortality after 10 years of follow-up, possibly extending to 15 years of follow-up

    10 years

Secondary Outcomes (3)

  • Colorectal cancer incidence

    10 years

  • Complications and quality assurance

    4 years

  • Psychological effects of screening

    5 years

Other Outcomes (2)

  • Bowel preparation in Sigmoidoscopy

    1 year start Fall 2017

  • Pain reduction during Colonoscopy

    18 months from Fall 2017

Study Arms (2)

Flexible sigmoidoscopy

EXPERIMENTAL

70,000 men and women at age 50-74 years are randomised from the population registry to be invited to have a screening examination using flexible sigmoidoscopy once-only

Procedure: Flexible sigmoidoscopy

iFOBT

EXPERIMENTAL

70,000 men and women at age 50-74 years randomised from the population registry to be invited to have a screening examination biennially using an immunochemical test for fecal occult blood testing (iFOBT).

Procedure: iFOBT

Interventions

Flexible sigmoidoscopyPROCEDURE

Flexible sigmoidoscopy screening is offered once only

Also known as: FlexSig= flexible sigmoidoscopy
Flexible sigmoidoscopy
iFOBTPROCEDURE

Biennial screening with iFOBT

Also known as: iFOBT = immunochemical test for fecal occult blood
iFOBT

Eligibility Criteria

Age50 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • men and women
  • age 50-74 years
  • living in defined geographic areas in South-East Norway (catchment areas for two hospitals)

You may not qualify if:

  • previous colorectal cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Moss Hospital

Oslo, 1535, Norway

Location

Bærum County Hospital

Rud, 1309, Norway

Location

Related Publications (12)

  • Rognstad OB, Botteri E, Hoff G, Bretthauer M, Nguyen HD, Schult AL, Holme O, Randel KR. Use of claims data to identify adverse events after colonoscopy in a randomised colorectal cancer screening trial in Norway: a cross-sectional study. BMJ Open. 2026 Jan 8;16(1):e109883. doi: 10.1136/bmjopen-2025-109883.

    PMID: 41506765DERIVED

  • Rognstad OB, Botteri E, Hoff G, Bretthauer M, Gulichsen E, Frigstad SO, Holme O, Randel KR. Adverse events after colonoscopy in a randomised colorectal cancer screening trial. BMJ Open Gastroenterol. 2024 Oct 7;11(1):e001471. doi: 10.1136/bmjgast-2024-001471.

    PMID: 39375173DERIVED

  • Randel KR, Botteri E, de Lange T, Schult AL, Eskeland SL, El-Safadi B, Norvard ER, Bolstad N, Bretthauer M, Hoff G, Holme O. Performance of Faecal Immunochemical Testing for Colorectal Cancer Screening at Varying Positivity Thresholds. Aliment Pharmacol Ther. 2025 Jan;61(1):122-131. doi: 10.1111/apt.18314. Epub 2024 Oct 7.

    PMID: 39373173DERIVED

  • Randel KR, Schult AL, Botteri E, Nawaz M, Nguyen DH, Holme O, Bretthauer M, Hoff G, de Lange T. Impact of inadequate bowel cleansing in sigmoidoscopy screening. Scand J Gastroenterol. 2024 Aug;59(8):1002-1009. doi: 10.1080/00365521.2024.2364213. Epub 2024 Jun 8.

    PMID: 38850200DERIVED

  • Ribe SG, Botteri E, Loberg M, Randel KR, Kalager M, Nilsen JA, Gulichsen EH, Holme O. Impact of time between faecal immunochemical tests in colorectal cancer screening on screening results: A natural experiment. Int J Cancer. 2023 Apr 1;152(7):1414-1424. doi: 10.1002/ijc.34351. Epub 2022 Nov 21.

    PMID: 36346118DERIVED

  • Schult AL, Botteri E, Hoff G, Holme O, Bretthauer M, Randel KR, Gulichsen EH, El-Safadi B, Barua I, Munck C, Nilsen LR, Svendsen HM, de Lange T. Women require routine opioids to prevent painful colonoscopies: a randomised controlled trial. Scand J Gastroenterol. 2021 Dec;56(12):1480-1489. doi: 10.1080/00365521.2021.1969683. Epub 2021 Sep 17.

    PMID: 34534048DERIVED

  • Kvaerner AS, Birkeland E, Bucher-Johannessen C, Vinberg E, Nordby JI, Kangas H, Bemanian V, Ellonen P, Botteri E, Natvig E, Rognes T, Hovig E, Lyle R, Ambur OH, de Vos WM, Bultman S, Hjartaker A, Landberg R, Song M, Blix HS, Ursin G, Randel KR, de Lange T, Hoff G, Holme O, Berstad P, Rounge TB. The CRCbiome study: a large prospective cohort study examining the role of lifestyle and the gut microbiome in colorectal cancer screening participants. BMC Cancer. 2021 Aug 18;21(1):930. doi: 10.1186/s12885-021-08640-8.

    PMID: 34407780DERIVED

  • Schult AL, Botteri E, Hoff G, Randel KR, Dalen E, Eskeland SL, Holme O, de Lange T. Detection of cancers and advanced adenomas in asymptomatic participants in colorectal cancer screening: a cross-sectional study. BMJ Open. 2021 Jul 1;11(7):e048183. doi: 10.1136/bmjopen-2020-048183.

    PMID: 34210732DERIVED

  • Randel KR, Schult AL, Botteri E, Hoff G, Bretthauer M, Ursin G, Natvig E, Berstad P, Jorgensen A, Sandvei PK, Olsen ME, Frigstad SO, Darre-Naess O, Norvard ER, Bolstad N, Korner H, Wibe A, Wensaas KA, de Lange T, Holme O. Colorectal Cancer Screening With Repeated Fecal Immunochemical Test Versus Sigmoidoscopy: Baseline Results From a Randomized Trial. Gastroenterology. 2021 Mar;160(4):1085-1096.e5. doi: 10.1053/j.gastro.2020.11.037. Epub 2020 Nov 21.

    PMID: 33227280DERIVED

  • Randel KR, Botteri E, Romstad KMK, Frigstad SO, Bretthauer M, Hoff G, de Lange T, Holme O. Effects of Oral Anticoagulants and Aspirin on Performance of Fecal Immunochemical Tests in Colorectal Cancer Screening. Gastroenterology. 2019 May;156(6):1642-1649.e1. doi: 10.1053/j.gastro.2019.01.040. Epub 2019 Jan 25.

    PMID: 30689972DERIVED

  • Kirkoen B, Berstad P, Botteri E, Dalen E, Nilsen JA, Hoff G, de Lange T, Bernklev T. Acceptability of two colorectal cancer screening tests: pain as a key determinant in sigmoidoscopy. Endoscopy. 2017 Nov;49(11):1075-1086. doi: 10.1055/s-0043-117400. Epub 2017 Sep 22.

    PMID: 28938500DERIVED

  • Kirkoen B, Berstad P, Botteri E, Avitsland TL, Ossum AM, de Lange T, Hoff G, Bernklev T. Do no harm: no psychological harm from colorectal cancer screening. Br J Cancer. 2016 Mar 1;114(5):497-504. doi: 10.1038/bjc.2016.14. Epub 2016 Feb 11.

    PMID: 26867161DERIVED

Related Links

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasmsAdenoma

Interventions

Occult Blood

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Giske Ursin, MD, PhD

    Norwegian Institute of Public Health

    STUDY DIRECTOR

  • Kristin Randel, MD, PhD

    Norwegian Institute of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 13, 2012

First Posted

February 24, 2012

Study Start

March 1, 2012

Primary Completion (Estimated)

December 1, 2034

Study Completion (Estimated)

December 1, 2034

Last Updated

April 14, 2026

Record last verified: 2026-04

Locations

NO(2)