Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT01538550 |
| Other study ID # |
CRCpilotNorway |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2012 |
| Est. completion date |
December 2030 |
Study information
| Verified date |
January 2021 |
| Source |
Cancer Registry of Norway |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
There are several candidate screening modalities - fecal occult blood (FOBT), flexible
sigmoidoscopy, colonoscopy, CT and MRI colonography and a range of molecular markers. Of
these, only FOBT and FS have been subjected to long-term follow-up in randomised trials
(RCTs). These two modalities will be tested in a head-to-head comparison by 1:1
randomisation. Previous studies have suggested that the attendance for FS may be lower than
for FOBT. However, participation has been shown to decline with repetitive rounds required
for FOBT, while infrequent or once-only screening may suffice for FS. A better test
performance for FS makes it uncertain which method may be most beneficial in a public health
perspective. This is the first time a national screening programme is designed as a platform
for comparative effectiveness studies.
The pilot study will be carried out in two hospital catchment areas in South-East Norway -
each with a target population of 70,000 men and women at 50-74 years of age - altogether
140,000 individuals to be randomised 1:1 between screening with an immunochemical test for
faecal occult blood (iFOBT) biennially or FS once only. The primary endpoint is colorectal
mortality reduction after 10 years. Attendance for FS is expected to be 50% and 60% for
iFOBT. Expected CRC mortality reduction is 30% (286 CRC deaths) in the FS arm and 15% (143
CRC deaths) in the iFOBT arm (intention-to-treat). In a 1:1 randomisation with 80%
statistical power and a significance level of 5% it will require 70,000 individuals in each
arm to disclose a statistically significant difference between FS and iFOBT screening in an
intention-to-treat model. We expect 5% in the iFOBTs group to test positive and require
colonoscopy work-up. A positive FS is defined as 'any advanced neoplasia' (CRC, adenoma
>10mm, adenoma with high-grade dysplasia or villous components). A finding of advanced
neoplasia is expected in 5% of FS requiring full colonoscopy.
Study entry-date: All individuals were randomized to each of the two groups (iFOBT or
sigmoidoscopy) before study start. Because first round screening of the iFOBT arm (70,000
invitees) will be finished in a shorter time frame compared to sigmoidoscopy, invitees in the
flexible sigmoidoscopy arm are prone to more relevant time-dependent events between
randomization and time of screening actually being offered. Therefore, primary entry-date was
defined as day of mailed invitation in both screening groups. This approach means that the
mean age at invitation in the sigmoidoscopy screening group will be older than in the iFOBT
group, and analyses have to take this age-difference into account. Randomization date was
chosen as a secondary study entry date to allow comparative analysis of effects of choosing
the two entry date definitions. Sub-studies on lifestyle, psychological reactions comparing
participants and control groups not invited to screening from neighbouring municipalities are
performed. A randomized sub-study comparing various premedication in work-up colonoscopies is
also performed.
Sub-studies
1. Changes in modifiable lifestyle factors such as not smoking, normal weight, high level
of physical activity may reduce the risk of CRC. Correlation between these factors and
endoscopic findings will be assessed. Limited intervention will be tested to improve
life style.
2. The effect of screening on Psychological factors and the willingness to repeat screening
will be assessed
3. Creation of a validated Sigmoidoscopy Bowel Preparation scale with subsequent testing of
various bowel preparation modalities will be performed.
4. RCT with various strategies og analgesia during colonoscopy will be tested to improve
patient experience.
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