Clinical trial · Interventional
NORCCAP: Norwegian Colorectal Cancer Prevention Trial
Norwegian Colorectal Cancer Prevention Trial
NCT00119912CI-TRIAL-00108184NORCCAPactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenoma | Adenoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| A 1 Intervention arm Flex Sig | Procedure | — | UNRESOLVED |
| A 2 Intervention arm Flex Sig + iFOBT | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- A 1 Intervention arm Flex Sig
- description
- 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..
- interventionNames
- Procedure: A 1 Intervention arm Flex Sig
- type
- NO_INTERVENTION
- label
- B Control arm
- description
- "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.
- type
- ACTIVE_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 64 Years
Show eligibility criteria text
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
References
Publications (30)
- BACKGROUNDHoff 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 19483252
- BACKGROUNDHolme 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 25399542
- BACKGROUNDBerstad 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 25183203
- BACKGROUNDHolme 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 25117129
- RESULTLarsen 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 17363335
- RESULTLarsen 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 16412216
- RESULTLarsen 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.