Screening for Stomach Diseases and Colorectal Neoplasms With the Fecal Testing

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01741363

Collaborator

(none)

40,000

Enrollment

Location

Arms

Duration (Months)

615.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The abundant results from this trial will be helpful for assessing the feasibility of increasing stool sampling and shortening screening interval in population setting for lower and upper gastrointestinal tract lesions, their long-term effects, and the respective cost-effectiveness.
The study will evaluate the value of population-based screen and treatment for H. pylori infection when the HPSA is combined with the FIT.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Stomach Disease	Other: FIT(Eiken OC-Sensor) Two-day sampling Other: FIT(Eiken OC-Sensor) One-year interval Other: FIT(Eiken OC-Sensor) One-day sampling Other: FIT(Eiken OC-Sensor) Two-year interval Other: HpSA (Firstep Helicobacter pylori Antigen Rapid Test)	N/A

Detailed Description

Growing body of evidences have shown that fecal immunochemical 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 69 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 firstly aim to randomly allocate screening attendee to one of the 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.

Secondly, in the Taiwanese population, which is a typical presentation of Asian populations, although the incidence of colorectal cancer is rapidly increasing, Helicobacter pylori-related upper gastrointestinal 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 the FIT does not predict upper GI pathologies, the adjunct of an「Helicobacter 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. Therefore, in the present study, we will also evaluate the value of simultaneous FIT and HpSA test in the community-based mass screening. We invited subjects in a randomized study to receive the FIT or the FIT plus HPSA. Those who are tested positive for HPSA will receive upper endoscopic examination and anti-H. pylori treatment. For the short-term indicators, we will evaluate the participation rate and diagnostic yield when the HPSA is added. For the long-term indicators, we will compare the incidence and mortality of gastric cancer as well as complicated peptic ulcers.

To summary, this study includes two randomized trials:

To make a comparison between 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 using FIT;
To make a comparison between FIT plus HpSA and FIT alone for screening.

Finally, the cost-effectiveness analysis will be also conducted using previously established Markov model of CRC natural history and stomach diseases (such as dyspepsia, peptic ulcer disease, and gastric cancer) using the results ascertained from this trial.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Screening for Stomach Diseases and Colorectal Neoplasms With the Fecal Testing: a Population-based Randomized Study

Study Start Date :

Jul 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: one-day sampling with one-year interval FIT one-day sampling with one-year interval	Other: FIT(Eiken OC-Sensor) One-year interval Screening with one-year interval Other: FIT(Eiken OC-Sensor) One-day sampling One-day sampling
Active Comparator: one-day sampling with two-year interval FIT one-day sampling with two-year interval	Other: FIT(Eiken OC-Sensor) One-day sampling One-day sampling Other: FIT(Eiken OC-Sensor) Two-year interval Screening with two-year interval
Experimental: two-day sampling with one-year interval FIT two-day sampling with one-year interval	Other: FIT(Eiken OC-Sensor) Two-day sampling Collect two stool samples in two separate days Other: FIT(Eiken OC-Sensor) One-year interval Screening with one-year interval
Experimental: two-day sampling with two-year interval FIT two-day sampling with two-year interval	Other: FIT(Eiken OC-Sensor) Two-day sampling Collect two stool samples in two separate days Other: FIT(Eiken OC-Sensor) Two-year interval Screening with two-year interval
Experimental: Hp stool antigen (HpSA)+FIT HpSA for detection of upper gastrointestinal tract diseases and upper endoscopy for H. pylori carriers; HPSA combined with FIT	Other: HpSA (Firstep Helicobacter pylori Antigen Rapid Test) HpSA for detection of upper gastrointestinal diseases; screen and treat for H. pylori infection. Upper endoscopy for H. pylori carriers. HPSA+FIT compared with FIT alone.

Outcome Measures

Primary Outcome Measures

Detection rate for advanced adenoma and cancer [6 years]
Detection rate for advanced adenoma per 1000 screened subjects and detection rate for invasive cancers per 1000 screened subjects
Detection rate of upper gastrointestinal tract diseases [6 years]
Detection rate for important upper gastrointestinal tract lesions and important upper gastrointestinal tract neoplastic lesions per 1000 screened subjects.

Secondary Outcome Measures

Participation rate for the FIT and/or HpSA [6 years]
participation rate=tested population/ target or invited population
Detection rates for non-advanced adenoma [6 years]
Detection rate for non-advanced adenoma per 1000 screened subjects
Confirmatory examination referral rate [6 years]
Subjects who received confirmatory examinations (colonoscopy or flexible sigmoidoscopy plus double contrast barium enema for lower gastrointestinal tract disease; esophagogastroduodenoscopy for upper gastrointestinal tract disease) / subjects with positive stool test (FIT or HpSA)
Mortality rate from colorectal cancer [Anticipated 10 years]
Number of colorectal cancer death / person-year of each study arm
Incidence of colorectal cancer [Anticipated 10 years]
Number of incident colorectal cancer / person-year of each study arm
Incidence of stomach cancer [Anticipated 10 years]
Number of incident stomach cancer / person-year of each study arm
Mortality rate from stomach cancer [Anticipated 10 years]
Number of stomach cancer death / person-year of each study arm
Helicobacter pylori eradication rate [6 years]
Subjects who received anti-H. pylori treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

50 to 75 years average-risk subjects for FIT
50 to 75 years subjects for HpSA

Exclusion Criteria:

Subjects who are unwilling to participate
Subjects ineligible for endoscopy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei		Taiwan	10002

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

Principal Investigator: Han-Mo Chiu, M.D., Ph.D., Department of Internal Medicine & Health Management Center
Principal Investigator: Yi-Chia Lee, M.D., Ph.D., National Taiwan University Hospital