Recruiting NCT06370143
A Study Collecting Health Information to Understand and Prevent Gastric Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Questionnaire.
- Who it may be relevant to
- Registry conditions: Gastric Atrophy, Gastric Intestinal Metaplasia, Dysplasia, Gastric Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Gastric Cancer Prevention: Understanding Precursor Lesions and Risk Factors for Progression to Cancer
Overview
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.
Interventions
- Behavioral Questionnaire
The questionnaire on clinical, environmental, lifestyle, and dietary risk factors will be administered
Primary outcome measures
- Creation of participant registry [Time frame: Up to 10 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 7 centers
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge
- Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale
- Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity) — Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison
- Memorial Sloan Kettering Cancer Center (All protocol activites) — New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activites) — Rockville Centre
Identifiers
NCT: NCT06370143 · 24-083