Individually Tailored Strategies for the Precision Prevention of Gastric Cancer and Colorectal Cancer in the Community

NCT03793335 | Enrolling By Invitation

• 1 other identifier: 201811034RINB
• Study Type: observational
• Target: 40,000
• Locations: 1 country
• Sites: 1

Brief Summary

Gastric cancer is a global health threat. Helicobacter pylori is now recognized as the main risk factor that initiates this process; hence, H. pylori eradication has been considered the most effective method to ameliorate the burden of gastric cancer. Serum pepsinogen levels reveal the current atrophy of the stomach and predict gastric cancer risk. A risk prediction model with the combination of H. pylori infection and serum pepsinogen level could identify the highest-risk gastric cancer patients. Colorectal cancers (CRC) rank second and third as the leading causes of cancer-related death in men and women, respectively. For CRC prevention, a two-stage approach using the fecal immunochemical test (FIT) is popular; besides, the FIT levels may serve as a guide for priority setting in prompting residents to undergo colonoscopy. Therefore, the effectiveness and utility of aggressive referral confirmatory diagnosis protocol in a colorectal cancer screening program for those with high FIT levels urgently need to evaluate.

Conditions

Gastric Cancer; Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• Gastric cancer prevention

  To assess the combination of H. pylori stool antigen test and serum pepsinogen test as a joint predictor of gastric cancer risk

  Up to 10 years, the gastric cancer incidence per 100,000 person-years is calculated by the person-years of follow-up.

• Colorectal cancer prevention

  To assess the effectiveness/utility of aggressive referral confirmatory diagnosis protocol in a colorectal cancer screening program

  Up to 10 years, the colorectal cancer incidence per 100,000 person-years is calculated by the person-years of follow-up.

Study Arms (2)

Gastric cancer prevention

This prospective study consists of 40,000 participants; after randomization, each arm has 20,000 participants. Arm 1: participants receive H. pylori stool antigen test; Arm 2: participants receive the combination of H. pylori stool antigen test and serum pepsinogen test.

Colorectal cancer prevention

This prospective study consists of 40,000 participants; after randomization; each arm has 20,000 participants. Arm 1: participants with positive fecal immunochemical test (FIT) receive routine referral confirmatory diagnosis approach; Arm 2: participants with positive FIT receive routine referral confirmatory diagnosis approach and participants with high FIT results receive additional aggressive referral confirmatory diagnosis approach.

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A community-based mass screening for gastric cancer and colorectal cancer is designed and targeted at community residents aged 50-75 years in Taiwan.

You may qualify if:

• Aged 50-75 years
• Confirmed non-gastric cancer/colorectal cancer healthy participant
• Mentally competent to be able to understand the consent form
• Able to communicate with study staff for individuals
• Agree to link the screening data to National Cancer Registry

You may not qualify if:

• Confirmed gastric cancer/colorectal cancer healthy participant
• Status post gastrectomy

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Stomach Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• TSUNG-HSIEN CHIANG, MD, MSc

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 4, 2019
• Study Start: April 14, 2019
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2029
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)