Screening for Stomach Diseases and Colorectal Neoplasms With the Fecal Testing: a Population-based Randomized Study
Phase: NA
Conditions: Colorectal Cancer, Stomach Disease
Sponsor: National Taiwan University Hospital

Protocol No.: 201205030RIB 
Confidential 
 
  
Protocol version: V1.0 
Date: May-30-2012 
CLINICAL STUDY PROTOCOL  
 
Screening for Colorectal Neoplasms with the Fecal 
Testing: a Population-based Randomized Study  
Protocol Number: 201205030RIB 
ClinicalTrial.gov Number: NCT 01741363 
  
 
 
 
 
 
Indication: 
Colorectal Neoplasms 
Principal Investigator:  Han-Mo Chiu, M.D., Ph.D. 
Version Number:  
V1.0  
Date 
May-30-2012 
Funding Support: 
Health Promotion Administration, Ministry of Health 
and Welfare 
 
 
 
 
 
 
 
 
All the information disclosed or provided by the Health Promotion Administration, Ministry of Health and 
Welfare or produced during the clinical trial, including this protocol, the CRFs, the Investigator Brochure, and 
the results obtained during the clinical trial, is confidential and is intended for the use of clinical investigators, 
and any person under his/her authority agree to keep confidential.  

                                                                                                                                       Protocol No：201205030RIB 
                                                                                                                                       Confidential 
Protocol version V1.0 
Data:May-30-2012 
ABSTRACT 
Screening f or stomach diseases and colorectal neoplasms with 
the fecal testing: a population-based randomized study 
 
 
Growing body of evidences have shown that fecal immune test (FIT) 
outperform guaiac fecal occult blood test (gFOBT) in terms of sensitivity, 
neoplasm detection rate and public participation. Though direct outcome 
evidence is still lacking for FIT, it is anticipated to have higher colorectal cancer 
(CRC) mortality and incidence reduction compared with gFOBT. In Taiwan, 
nation-wide  CRC  screening  program  has  been  launched  since  the  year  of 
2004 ,which provides biennial FIT screening for adults aged 50 to 75 years. 
Currently available data from the Bureau of Health Promotion has shown a 
significant stage-shift effect, an early indicator of screening effectiveness, by this 
screening program. 
 
Nevertheless the aforementioned advantages of FIT, missed neoplasms and 
interval cancer still exists under the current one-day stool sampling method 
with biennial screening interval, which might affect the effectiveness of overall 
screening program.   Increase the number of stool samples or shortening of 
screening interval may be helpful for early detection of clinically significant 
neoplasms but it remains unclear whether such an approach may lower the 
screenee  compliance  or  public  participation.  Moreover,  its  impact  on  the 
demand of confirmatory colonoscopy and cost-effectiveness of the whole 
screening program is still largely unknown and need to be further investigated. 
 
In this study, we aim to randomly allocate screening attendee to one of the 

                                                                                                                                       Protocol No：201205030RIB 
                                                                                                                                       Confidential 
Protocol version V1.0 
Data:May-30-2012 
following four arms: one-day sampling with annual screening, one-day sampling 
with biennial screening, two-day sampling with annual screening, and two-day 
sampling with biennial screening. Participation rate, positive rates of FIT, 
detection rate for neoplasms, positive predictive value, and long-term outcome 
including cancer incidence and mortality will be calculated and compared among 
four groups. In addition, cost-effectiveness analysis will be also conducted using 
previously established Markov model of CRC natural history using the results 
ascertained from this trial. 
 
The abundant results from this trial will be helpful for assessing the feasibility 
of increasing stool sampling and shortening screening interval in population 
setting, their long-term effects, and cost-effectiveness. 
 
However, in Taiwan, although the incidence of colorectal cancer is rapidly 
increasing, Helicobacter pylori-related upper GI pathologies remain highly 
prevalent, which may imply that mass screening solely based on FIT could be 
insufficient as significant upper GI pathologies can be missed. Since FIT dose not 
predict upper GI pathologies, the adjuncts of H. pylori stool-antigen test (HpSA) 
may be a potential candidate to realize a pan-detecting assay based on stool 
samples in a population in which both lower and upper GI lesions are equally 
prevalent.