DESCRIPTION (Applicant's Description) Colorectal cancer (CRC) screening
reduces mortality, but it remains unclear whether the combination of a fecal
occult blood test (FOBT) and sigmoidoscopy offers any advantage over either
method used alone. Kaiser Permanente has begun a population CRC screening
program based on the use of sigmoidoscopy every 10 years. FOBT has not been
included due to the low sensitivity of unrehydrated Hemoccult and the low
specificity of the rehydrated Hemoccult. A combination FOBT consisting of a
high sensitivity guaiac-based test (Hemoccult Sensa) and an immunochemical
test (HemeSelect/FlexSure OBT) offers increased sensitivity with preserved
We propose to evaluate the benefit of adding the combination FOBT to a
screening sigmoidoscopy protocol in an estimated 16,000 patients of average
risk for colorectal cancer. Patients will be tested with the combination
FOBT prior to sigmoidoscopy. Those testing positive will have colonoscopy;
negatives will have sigmoidoscopy. Patients not colonoscoped in year 1 will
be retested in year 2. Patients will be enrolled over a two year period,
receiving up to two combination FOBT, 12 months apart. This is an outcomes
oriented study, using computerized Kaiser Permanente databases to track
sigmoidoscopy, colonoscopy, and pathology results, and a regional cancer
registry to track cancer incidence during a 2 year follow-up period.
We will evaluate the following effects of adding the combination FOBT to
sigmoidoscopy: (1) the added diagnostic yield; (2) the diagnostic burden
(i.e., the colonoscopy rate); and (3) the effect on compliance with
screening. Results will be compared with subjects at the same facilities
prior to starting the combined strategy (historical controls), to
non-random, concurrent controls being screened elsewhere with
sigmoidoscopy-only, and to internal controls by using the yield of advanced
proximal neoplasms detectable only with the combined strategy. Finally,
this study will be used to modify a cost-effectiveness model of CRC
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