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The GAstric Precancerous Conditions Study

NCT ID: NCT04191551

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-30

Study Completion Date

2028-06-30

Brief Summary

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Gastric cancer afflicts 27,000 Americans annually and carries a dismal prognosis. One reason for poor outcomes is late diagnosis, as the majority of gastric cancers in the United States are diagnosed at a relatively advanced stage where curative resection is unlikely. Gastric precursors (such as atrophic gastritis and intestinal metaplasia) are precancerous changes to the stomach mucosa which increases risk for subsequent gastric cancer.

The Gastric Precancerous Conditions Study (GAPS) is an observational study of patients at elevated risk for gastric cancer. Investigators seek to recruit patients from endoscopy unit of Stanford Health Care, a large academic network of hospitals and clinics serving Northern California. Investigators will recruit patients who are both symptomatic (e.g. dyspepsia) and asymptomatic (e.g. referred for screening), and individuals both with known precursor lesions (such as intestinal metaplasia) or at high risk for carrying precursor lesions. A component of the study is long-term follow-up of individuals with gastric precursors. This is to understand their risk factors for histologic progression and regression. During both index and subsequent endoscopies, the study team will collect biospecimens (e.g. blood, saliva, gastric tissue).

Detailed Description

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Conditions

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Gastric Cancer Intestinal Metaplasia of Gastric Mucosa Helicobacter Pylori Infection Atrophic Gastritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Precursor lesions

Subjects with precursor lesions detected on endoscopy.

No interventions assigned to this group

Eligibility Criteria

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Exclusion Criteria

* Cannot give consent
* Have history of gastric surgery
* Have history of solid tumor or bone marrow transplant
* Platelet Count \< 70 or international normalized ratio \> 1.5
Minimum Eligible Age

35 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert J Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Joo Ha Hwang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Stanford, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Robert J Huang, MD

Role: CONTACT

[email protected]
650-725-0634

Facility Contacts

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Robert J Huang, MD

Role: primary

[email protected]
650-725-0634

Other Identifiers

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NCI-2020-13776

Identifier Type: REGISTRY

Identifier Source: secondary_id

IRB-45077

Identifier Type: -

Identifier Source: org_study_id