Screening for Stomach Diseases and Colorectal Neoplasms With the Fecal Testing

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.

Conditions

• Colorectal Cancer
• Stomach Disease

Interventions

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

OTHER

FIT(Eiken OC-Sensor) One-day sampling

One-day sampling

OTHER

FIT(Eiken OC-Sensor) Two-year interval

Screening with two-year interval

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.

OTHER

FIT only

HPSA+FIT compared with FIT alone.

Sponsors & Collaborators

• Ministry of Health and Welfare, Taiwan

  collaborator OTHER_GOV

• National Taiwan University Hospital

  lead OTHER

Principal Investigators

• Han-Mo Chiu, M.D., Ph.D. · Department of Internal Medicine & Health Management Center

• Yi-Chia Lee, M.D., Ph.D. · National Taiwan University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

69 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-01-01

Primary Completion

2020-12-31

Completion

2020-12-31

Countries

• Taiwan

Study Locations