Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06370143

A Study Collecting Health Information to Understand and Prevent Gastric Cancer

The purpose of this study is to create a registry of participants with precursor lesions for gastric cancer, including gastric atrophy, intestinal metaplasia, and dysplasia. Normal controls and individuals with gastric cancer for comparison of baseline characteristics will also be enrolled.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age ≥ 18 years old
  • Able to read and understand English and Spanish
  • Meet criteria for one of three potentially eligible study populations:
  • Individuals with gastric atrophy, gastric intestinal metaplasia, or dysplasia: Had a previous diagnosis of or have been diagnosed by the investigation team with gastric atrophy, gastric intestinal metaplasia, or dysplasia of the gastric mucosa on pathology review from an endoscopic biopsy. Individuals who have a prior history of early gastric cancer may be included, if they were treated endoscopically and have no evidence of disease. Individuals who have a prior history of a cancer other than upper gastrointestinal cancer may also be included, if they have no evidence of disease for at least 1 year prior to study enrollment and are not undergoing active treatment for any malignancy at any time throughout the study period
  • Healthy controls (average risk): Individuals with no history of cancer or gastric precursor lesions undergoing a clinically indicated endoscopy at MSK for workup or dyspepsia or reflux
  • Gastric cancer cases: Individuals with a known diagnosis of early gastric adenocarcinoma undergoing surgical resection at MSK

Exclusion criteria

  • Age < 18 years old
  • Women who are pregnant (may be enrolled after delivery)
  • Individuals with a prior history of upper gastrointestinal surgery or a prior cancer who are undergoing active treatment for malignancy or have been diagnosed within 1 year prior to the study enrollment or with pancreatic cancer. (This does not include incidentally diagnosed primary gastric adenocarcinoma identified during study follow up. Individuals diagnosed with gastric carcinoid limited to the stomach will also be included, given their ongoing parallel risk for gastric adenocarcinoma.)
  • Have severe comorbidities with expected survival time <2 years or which would prevent them from undergoing routine elective EGD (at the discretion of the patient's provider and the study team)
  • Individuals having Hereditary Diffuse Gastric Cancer Syndrome, mutations including CDH1 and CTNNA1, or more than one genetic mutation
  • Exclude high risk esophageal and duodenal lesions including:
  • Duodenal Adenoma
  • Dysplasia or cancer at the esophagus or gastroesophageal junction
  • Patients with an increased risk for biopsies during EGD, such as those with clotting disorders.

Treatment and study plan

Questionnaire

Behavioral

The questionnaire on clinical, environmental, lifestyle, and dietary risk factors will be administered

Primary outcomes

  1. Creation of participant registry

    Time frame: Up to 10 years

    The primary objective of this study is to create a registry of individuals with precursor lesions for gastric cancer, including gastric atrophy, intestinal metaplasia, and dysplasia. Normal controls and individuals with gastric cancer for comparison of baseline characteristics will also be enrolled.

Study contacts

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

Monika Laszkowska, MD

CONTACT

[email protected]

212-639-6857

Xiang Shu, PhD

CONTACT

[email protected]

646-227-3658

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Gastric Cancer Prevention: Understanding Precursor Lesions and Risk Factors for Progression to Cancer

Important dates

Study start
2024
Primary completion
2036
Study completion
2036
First posted
Apr 17, 2024
Registry last updated
Jan 30, 2026

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.

Published trials that share one or more normalized conditions with this study.