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NCT Number: NCT04191551

The GAstric Precancerous Conditions Study

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).

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Key information

Conditions

Gastric Cancer Atrophic Gastritis Digestive System Diseases Digestive System Neoplasms Gastritis Gastritis, Atrophic Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Helicobacter Pylori Infection Intestinal Metaplasia of Gastric Mucosa Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

35 year–84 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University

Stanford, California, 94305, United States

Location status: Recruiting

Location contact

Robert J Huang, MD

CONTACT

[email protected]

650-725-0634

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects between the ages of 35 and 84, who are undergoing outpatient endoscopy for the following indications are eligible: abdominal pain, dyspepsia, iron deficiency anemia, Helicobacter assessment, surveillance of suspected or known intestinal metaplasia, evaluation for family history of gastric cancer

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

Treatment and study plan

Primary outcomes

  1. Histologic Progression or Regression Assessed by OLGA Score

    Time frame: at least 24 months after enrollment

    Histologic progression or regression will be evaluated using the Operative Link on Gastritis Assessment (OLGA) score. This score stages the severity of atrophic gastritis based on histological findings.

  2. Histologic Progression or Regression Assessed by OLGIM Score

    Time frame: at least 24 months after enrollment

    Histologic progression or regression will be assessed using the Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM) score. This score stages the extent of intestinal metaplasia.

  3. Development of Dysplasia

    Time frame: at least 24 months after enrollment

    The presence or absence of dysplasia will be assessed as an indicator of histologic progression.

  4. Development of Carcinoma

    Time frame: at least 24 months after enrollment

    The presence or absence of carcinoma will be assessed to evaluate disease progression.

Study contacts

Contact information is provided by the study sponsor or research team.

Robert J Huang, MD

CONTACT

[email protected]

650-725-0634

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Acronym: GAPS

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Dec 9, 2019
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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