A Study Collecting Health Information to Understand and Prevent Gastric Cancer
Gastric Cancer Prevention: Understanding Precursor Lesions and Risk Factors for Progression to Cancer
1 other identifier
observational
3,200
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2024
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 11, 2024
CompletedFirst Submitted
Initial submission to the registry
April 12, 2024
CompletedFirst Posted
Study publicly available on registry
April 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 11, 2036
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 11, 2036
January 30, 2026
January 1, 2026
12 years
April 12, 2024
January 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Creation of participant registry
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.
Up to 10 years
Study Arms (3)
Participants with atrophic gastritis, intestinal metaplasia, and dysplasia
Participants with presence of atrophic gastritis, intestinal metaplasia, and dysplasia and risk of the progression of these lesions
Control Group
Healthy controls
Participants with gastric cancer
Participants with gastric cancer
Interventions
The questionnaire on clinical, environmental, lifestyle, and dietary risk factors will be administered
Eligibility Criteria
Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan Kettering (MSK).
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All protocol activites)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Monika Laszkowska, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2024
First Posted
April 17, 2024
Study Start
April 11, 2024
Primary Completion (Estimated)
April 11, 2036
Study Completion (Estimated)
April 11, 2036
Last Updated
January 30, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.