With a targeted sample size of 150,000 participants to be
screened for CCA, we expect to detect early stage CCA at
a rate as low as one per 1000 with a precision of no more
than ±0.16 per 1000. A minimum of 1500 early stage CCA
patients is sufficient to demonstrate the efficacy of the
various treatment protocols provided to this cohort compared
to the patient group at late stage detection, as well
as comparing across the treatment protocols. At the end
of the recruitment period, we expect to achieve a total
sample size of 25,000 patients with some stage of the disease.
This sample size would allow us to calculate a hazard
ratio (HR) of at least 1.5, with a power of greater than
99 % for progression-free survival comparing either across
treatment protocols or disease stages. This was estimated
based on an assumption of the overall anticipated event
rate of 0.5 with a correlation among covariates of 0.1 and
based on using cox regression as the statistical method.