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Screening for Stomach Diseases and Colorectal Neoplasms With the Fecal Testing

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01741363
First received: October 5, 2012
Last updated: September 2, 2014
Last verified: September 2014
  Purpose
  1. 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.
  2. 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 Intervention
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)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Screening for Stomach Diseases and Colorectal Neoplasms With the Fecal Testing: a Population-based Randomized Study

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Detection rate for advanced adenoma and cancer [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    participation rate=tested population/ target or invited population

  • Detection rates for non-advanced adenoma [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    Detection rate for non-advanced adenoma per 1000 screened subjects

  • Confirmatory examination referral rate [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Anticipated 10 years ] [ Designated as safety issue: No ]
    Number of colorectal cancer death / person-year of each study arm

  • Incidence of colorectal cancer [ Time Frame: Anticipated 10 years ] [ Designated as safety issue: No ]
    Number of incident colorectal cancer / person-year of each study arm

  • Incidence of stomach cancer [ Time Frame: Anticipated 10 years ] [ Designated as safety issue: No ]
    Number of incident stomach cancer / person-year of each study arm

  • Mortality rate from stomach cancer [ Time Frame: Anticipated 10 years ] [ Designated as safety issue: No ]
    Number of stomach cancer death / person-year of each study arm

  • Helicobacter pylori eradication rate [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    Subjects who received anti-H. pylori treatment.


Estimated Enrollment: 40000
Study Start Date: July 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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:

  1. 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;
  2. 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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01741363

Contacts
Contact: Han-Mo Chiu, M.D., Ph.D. +886-2-23123456 ext 63354 hanmochiu@ntu.edu.tw
Contact: Yi-Chia Lee, M.D., Ph.D. +886-2-23123456 ext 63351 yichialee@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Contact: Han-Mo Chiu, M.D., Ph.D.    +886-2-23123456 ext 63354 ext 63354    hanmochiu@ntu.edu.tw   
Contact: Yi-Chia Lee, M.D., Ph.D.    +886-2-23123456 ext 63351 ext 63351    yichialee@ntu.edu.tw   
Principal Investigator: Han-Mo Chiu, M.D., Ph.D.         
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
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01741363     History of Changes
Other Study ID Numbers: 201205030RIB
Study First Received: October 5, 2012
Last Updated: September 2, 2014
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
iFOBT
one-day sample
two-day sample
Helicobacter pylori stool antigen

Additional relevant MeSH terms:
Stomach Diseases
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 30, 2014