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NORCCAP

Norwegian Colorectal Cancer Prevention Trial: flexible sigmoidoscopy screening

N = 100,210NCT00119912

Population
People aged 50 to 64 years from Oslo and Telemark, Norway; 98,792 were included in the intention-to-screen analyses (2014 report).
Design
Population-based randomised clinical trial in Oslo city and Telemark County, Norway, of 100,210 people aged 50 to 64. Screening took place in 1999-2000 (ages 55-64) and 2001 (ages 50-54). Participants randomised to screening were randomised 1:1 to once-only flexible sigmoidoscopy or once-only flexible sigmoidoscopy plus faecal occult-blood testing; positive results (cancer, adenoma, polyp of at least 10 mm, or positive FOBT) led to colonoscopy. The control group received no intervention.
Primary endpoint
Colorectal cancer incidence, Colorectal cancer mortality
Arms
  • Invited to screening (experimental, n = 20,572): Once-only flexible sigmoidoscopy, or once-only flexible sigmoidoscopy plus faecal occult-blood testing (1:1)
  • No screening (control, n = 78,220): No intervention
People
Holme Ø
Colorectal cancer mortalityHR 0.73 (95% CI 0.56–0.94)Colorectal cancer incidenceHR 0.80 (95% CI 0.70–0.92)Colorectal cancer mortalityHR 0.63 (95% CI 0.47–0.83)Δ Colorectal cancer mortality−0.32 pointsColorectal cancer mortalityHR 1.01 (95% CI 0.77–1.33)Δ Colorectal cancer mortality+0.01 points
Show the numbers
Results reported for NORCCAP
EndpointAnalysisInvited to screeningNo screeningEffect
Colorectal cancer mortalityIntention-to-screen analysis (98,792 participants)primarymedian follow-up 10.9 yearsHolme 2014——HR 0.73 (95% CI 0.56–0.94)71 deaths in the screening group and 330 in the control group (31.4 vs 43.1 per 100,000 person-years; absolute rate difference 11.7, 95% CI 3.0 to 20.4). Adherence with screening was 63%. No difference between the sigmoidoscopy-only and sigmoidoscopy plus FOBT groups.
Colorectal cancer incidenceIntention-to-screen analysis (98,792 participants)primarymedian follow-up 10.9 yearsHolme 2014——HR 0.80 (95% CI 0.70–0.92)253 cases in the screening group and 1086 in the control group (112.6 vs 141.0 per 100,000 person-years).
Colorectal cancer mortalityMen (sex-stratified analysis)long term-updatemedian follow-up 14.8 yearsHolme 20180.49%0.81%HR 0.63 (95% CI 0.47–0.83)Absolute risks of death from colorectal cancer; risk difference -0.33 percentage point. Age-adjusted absolute risks and hazard ratio as reported. The abstract states '95% CI' for the risk-difference interval and writes 'CI' for the hazard-ratio interval in the same sentence; read as 95%. P for heterogeneity between women and men 0.014.
Colorectal cancer mortalityWomen (sex-stratified analysis)long term-updatemedian follow-up 14.8 yearsHolme 20180.6%0.59%HR 1.01 (95% CI 0.77–1.33)Absolute risks of death from colorectal cancer; risk difference 0.01 percentage point. Age-adjusted absolute risks and hazard ratio as reported. The abstract states '95% CI' for the risk-difference interval and writes 'CI' for the hazard-ratio interval in the same sentence; read as 95%. P for heterogeneity between women and men 0.014.
Colorectal cancer incidenceMen (sex-stratified analysis)long term-updatemedian follow-up 14.8 yearsHolme 20181.72%2.5%HR 0.66 (95% CI 0.57–0.78)Absolute risks of colorectal cancer; risk difference -0.78 percentage point. Age-adjusted absolute risks and hazard ratio as reported. The abstract states '95% CI' for the risk-difference interval and writes 'CI' for the hazard-ratio interval in the same sentence; read as 95%. P for heterogeneity 0.004.
Colorectal cancer incidenceWomen (sex-stratified analysis)long term-updatemedian follow-up 14.8 yearsHolme 20181.86%2.05%HR 0.92 (95% CI 0.79–1.07)Absolute risks of colorectal cancer; risk difference -0.19 percentage point. Age-adjusted absolute risks and hazard ratio as reported. The abstract states '95% CI' for the risk-difference interval and writes 'CI' for the hazard-ratio interval in the same sentence; read as 95%. P for heterogeneity 0.004.
Results reported for NORCCAP
EndpointAnalysisInvited to screeningNo screeningEffect
Colorectal cancer mortalityIntention-to-screen analysis (98,792 participants)primarymedian follow-up 10.9 yearsHolme 2014——HR 0.73 (95% CI 0.56–0.94)71 deaths in the screening group and 330 in the control group (31.4 vs 43.1 per 100,000 person-years; absolute rate difference 11.7, 95% CI 3.0 to 20.4). Adherence with screening was 63%. No difference between the sigmoidoscopy-only and sigmoidoscopy plus FOBT groups.
Colorectal cancer incidenceIntention-to-screen analysis (98,792 participants)primarymedian follow-up 10.9 yearsHolme 2014——HR 0.80 (95% CI 0.70–0.92)253 cases in the screening group and 1086 in the control group (112.6 vs 141.0 per 100,000 person-years).
Colorectal cancer mortalityMen (sex-stratified analysis)long term-updatemedian follow-up 14.8 yearsHolme 20180.49%0.81%HR 0.63 (95% CI 0.47–0.83)Absolute risks of death from colorectal cancer; risk difference -0.33 percentage point. Age-adjusted absolute risks and hazard ratio as reported. The abstract states '95% CI' for the risk-difference interval and writes 'CI' for the hazard-ratio interval in the same sentence; read as 95%. P for heterogeneity between women and men 0.014.
Colorectal cancer mortalityWomen (sex-stratified analysis)long term-updatemedian follow-up 14.8 yearsHolme 20180.6%0.59%HR 1.01 (95% CI 0.77–1.33)Absolute risks of death from colorectal cancer; risk difference 0.01 percentage point. Age-adjusted absolute risks and hazard ratio as reported. The abstract states '95% CI' for the risk-difference interval and writes 'CI' for the hazard-ratio interval in the same sentence; read as 95%. P for heterogeneity between women and men 0.014.
Colorectal cancer incidenceMen (sex-stratified analysis)long term-updatemedian follow-up 14.8 yearsHolme 20181.72%2.5%HR 0.66 (95% CI 0.57–0.78)Absolute risks of colorectal cancer; risk difference -0.78 percentage point. Age-adjusted absolute risks and hazard ratio as reported. The abstract states '95% CI' for the risk-difference interval and writes 'CI' for the hazard-ratio interval in the same sentence; read as 95%. P for heterogeneity 0.004.
Colorectal cancer incidenceWomen (sex-stratified analysis)long term-updatemedian follow-up 14.8 yearsHolme 20181.86%2.05%HR 0.92 (95% CI 0.79–1.07)Absolute risks of colorectal cancer; risk difference -0.19 percentage point. Age-adjusted absolute risks and hazard ratio as reported. The abstract states '95% CI' for the risk-difference interval and writes 'CI' for the hazard-ratio interval in the same sentence; read as 95%. P for heterogeneity 0.004.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
Colorectal cancer mortalityColorectal cancer incidenceColorectal cancer mortalityColorectal cancer mortalityColorectal cancer incidenceColorectal cancer incidence0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
Colorectal cancer mortality0.730.56–0.94
Colorectal cancer incidence0.80.7–0.92
Colorectal cancer mortality0.630.47–0.83
Colorectal cancer mortality1.010.77–1.33
Colorectal cancer incidence0.660.57–0.78
Colorectal cancer incidence0.920.79–1.07
Primary publication: Holme Ø, Løberg M, Kalager M, Bretthauer M, Hernán MA, Aas E, et al. Effect of flexible sigmoidoscopy screening on colorectal cancer incidence and mortality: a randomized clinical trial. JAMA. 2014;312(6):606-15. PubMedDOI

Appears in

Sources

  1. Holme Ø, Løberg M, Kalager M, Bretthauer M, Hernán MA, Aas E, et al. Effect of flexible sigmoidoscopy screening on colorectal cancer incidence and mortality: a randomized clinical trial. JAMA. 2014;312(6):606-15.

    PubMedDOI

  2. Holme Ø, Løberg M, Kalager M, Bretthauer M, Hernán MA, Aas E, et al. Long-Term Effectiveness of Sigmoidoscopy Screening on Colorectal Cancer Incidence and Mortality in Women and Men: A Randomized Trial. Ann Intern Med. 2018;168(11):775-782.

    PubMedDOI