Screening for Stomach Diseases and Colorectal Neoplasms With the Fecal Testing

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01741363
• Other study ID #: 201205030RIB
• Status: Recruiting
• Phase: N/A
• First received: October 5, 2012
• Last updated: October 23, 2015
• Start date: July 2012
• Est. completion date: December 2017

Study information

• Verified date: October 2015
• Source: National Taiwan University Hospital
• Contact: Han-Mo Chiu, M.D., Ph.D.
• Phone: +886-2-23123456 ext 63354
• Email: hanmochiu[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40000
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Neoplasms
• Stomach Disease
• Stomach Diseases

Intervention

Other:
• FIT(Eiken OC-Sensor) Two-day sampling
Collect two stool samples in two separate days
• FIT(Eiken OC-Sensor) One-year interval
Screening with one-year interval
• FIT(Eiken OC-Sensor) One-day sampling
One-day sampling
• FIT(Eiken OC-Sensor) Two-year interval
Screening with two-year interval
• 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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection rate for advanced adenoma and cancer	Detection rate for advanced adenoma per 1000 screened subjects and detection rate for invasive cancers per 1000 screened subjects	6 years
Primary	Detection rate of upper gastrointestinal tract diseases	Detection rate for important upper gastrointestinal tract lesions and important upper gastrointestinal tract neoplastic lesions per 1000 screened subjects.	6 years
Secondary	Participation rate for the FIT and/or HpSA	participation rate=tested population/ target or invited population	6 years
Secondary	Detection rates for non-advanced adenoma	Detection rate for non-advanced adenoma per 1000 screened subjects	6 years
Secondary	Confirmatory examination referral rate	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)	6 years
Secondary	Mortality rate from colorectal cancer	Number of colorectal cancer death / person-year of each study arm	Anticipated 10 years
Secondary	Incidence of colorectal cancer	Number of incident colorectal cancer / person-year of each study arm	Anticipated 10 years
Secondary	Incidence of stomach cancer	Number of incident stomach cancer / person-year of each study arm	Anticipated 10 years
Secondary	Mortality rate from stomach cancer	Number of stomach cancer death / person-year of each study arm	Anticipated 10 years
Secondary	Helicobacter pylori eradication rate	Subjects who received anti-H. pylori treatment.	6 years