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Gastric CancerNCT03793335

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

An observational study of Gastric Cancer and Colorectal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Gastric Cancer, Colorectal Cancer
How many people
40,000 participants
Where
1 siteTaiwan
Study dates
14 Apr 2019to 31 Dec 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Taiwan1 site
  • National Taiwan University Hospital

    Taipei

Other trials in Taiwan

About this study

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.

Read the detailed description

Gastric cancer is a global health threat and contributes to more than 720,000 deaths per year. In the absence of early detection, gastric cancer is associated with a high fatality rate-the 5-year survival rate for patients with locally advanced disease is only about 40% despite aggressive treatment. Carcinogenesis in gastric cancer follows a multistage process (i.e., Correa's model) that develops from chronic active gastritis to atrophic gastritis, intestinal metaplasia, dysplasia, and finally to carcinoma. Helicobacter pylori is now recognized as the main risk factor that initiates this process. An estimated 89% of non-cardiac cancers can be prevented if H. pylori can be eradicated from the population of interest; hence, H. pylori eradication has been considered the most effective method to ameliorate the burden of gastric cancer. However, in the setting of mass screening, irreversible damage may already have occurred after patients have harbored H. pylori infection for decades before they undergo screening and treatment for H. pylori. This observation has been supported by a recent meta-analysis based on 8 randomized controlled trials and 16 cohort studies that investigated the magnitude of the benefit from eradication therapy; on average, only a 50% reduction of gastric cancer risk was shown. Altered levels of serum pepsinogens, which are mainly produced by the chief cells of the fundic glands of the stomach, reflect the atrophic status (ie, gland loss) of gastric mucosa. Serum pepsinogen levels not only reveal the past infection status or current atrophy of the stomach, respectively, but have also been shown to be predictive of gastric cancer risk. Therefore, to completely eliminate the burden of gastric cancer, physicians urgently need a risk prediction model with the combination of H. pylori infection and serum pepsinogen level to identify the highest-risk patients for endoscopic examination in the context of limited resources.

Colorectal cancers (CRC) rank second and third as the leading causes of cancer-related death in men and women, respectively, in the world. To reduce the burden of CRC, colonoscopy is the most effective method and can reduce the risk of new-onset CRCs by the removal of adenomatous polyps and can improve CRC survival by the detection of pre-symptomatic malignancies. In addition to primary screening colonoscopy, a two-stage approach using the fecal immunochemical test (FIT) is increasingly popular because of its ability to identify patients with the highest risk of CRC; in this manner, limited colonoscopist resources can be efficiently allocated. Although colonoscopy is associated with a statistically significant reduction in mortality rates for CRC through the detection of early-stage cancers, the FIT levels may serve as a guide for priority setting in prompting residents to undergo colonoscopy. Besides, the prevalence of any CRC and advanced-stage CRC is associated with delays in follow-up colonoscopies for patients with positive results from a FIT. 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.

Medical subject headings
Stomach Neoplasms, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03793335
Study groupRoleWhat they receive
Gastric cancer preventionThis 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 preventionThis 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. Colorectal cancer prevention

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2019
  2. Study start14 Apr 2019
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Prospective
Enrolment
40,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03793335
Sponsor's protocol ID
201811034RINB
Status last verified
Dec 2025
First submitted
2 Jan 2019
Last updated
18 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No individual participant data could be shared.

Questions about this trial

What is this clinical trial studying?

An observational study of Gastric Cancer and Colorectal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gastric cancer prevention (time frame: Up to 10 years, the gastric cancer incidence per 100,000 person-years is calculated by the person-years of follow-up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.

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