A Study Collecting Health Information to Understand and Prevent Gastric Cancer

Recruiting

• Conditions: Gastric Intestinal Metaplasia; Gastric Adenocarcinoma; Gastric Cancer; Gastric Atrophy; Dysplasia
• Interventions: Behavioral: Questionnaire

• Registration Number: NCT06370143
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-11
• Study First Submitted: 2024-04-12
• Study First Submitted QC: 2024-04-12
• Study First Posted: 2024-04-17
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2036-04-11
• Study Completion: 2036-04-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3200

Inclusion Criteria

• Age ≥ 18 years old

• Able to read and understand English

• Meet criteria for one of three potentially eligible study populations:

  • Individuals with gastric atrophy, gastric intestinal metaplasia, or dysplasia (increased risk): 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. (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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with gastric cancer	Questionnaire	Participants with gastric cancer
Control Group	Questionnaire	Healthy controls
Participants with atrophic gastritis, intestinal metaplasia, and dysplasia	Questionnaire	Participants with presence of atrophic gastritis, intestinal metaplasia, and dysplasia and risk of the progression of these lesions

Primary Outcome Measures

Name	Time	Method
Creation of participant registry	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.

Trial Locations

Locations (7)

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

Memorial Sloan Kettering Bergen (Limited Protocol Activities); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Cancer Center (All protocol activites); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activites); 🇺🇸 Rockville Centre, New York, United States

Memorial Sloan Kettering Monmouth (All Protocol Activities); 🇺🇸 Middletown, New Jersey, United States