Recruiting

Observational StudyA Study Collecting Health Information to Understand and Prevent Gastric Cancer

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06370143

Conditions

Gastric Atrophy

Gastric Intestinal Metaplasia

Dysplasia

Gastric Adenocarcinoma

Gastric Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Questionnaire

Study Details

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.

Conditions

Gastric Atrophy

Gastric Intestinal Metaplasia

Dysplasia

Gastric Adenocarcinoma

Gastric Cancer

Study ID

NCT06370143

Start date

Apr 11, 2024

Status verified date

Jan, 2026

Completion date

Apr 11, 2036

Anticipated

Primary completion date

Apr 11, 2036

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

3200 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

Questionnaire

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

Primary outcome measure

Creation of participant registry [ Time Frame: Up to 10 years ]

Central Contacts and Locations

Central contacts

Monika Laszkowska, MD

212-639-6857 LaszkowM@mskcc.org

Xiang Shu, PhD

646-227-3658 ShuX@mskcc.org

Locations

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Monika Laszkowska, MD

212-639-6857

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Monika Laszkowska, MD

212-639-6857

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Monika Laszkowska, MD

212-639-6857

Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)

Recruiting

Commack, New York, United States, 11725

Contacts

Monika Laszkowska, PhD

212-639-6857

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Monika Laszkowska, MD

212-639-6857

Memorial Sloan Kettering Cancer Center (All protocol activites)

Recruiting

New York, New York, United States, 10065

Contacts

Monika Laszkowska, MD

212-639-6857

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Monika Laszkowska, MD

212-639-6857

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jan 30, 2026

Last verified

Jan, 2026

Keywords

Gastric cancer
gastric adenocarcinoma
gastric atrophy
Gastric Intestinal Metaplasia
dysplasia
Memorial Sloan Kettering Cancer Center
24-083

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-01-30.