Collecting health information to understand and prevent gastric cancer
Gastric Cancer Prevention: Understanding Precursor Lesions and Risk Factors for Progression to Cancer
This study is trying to gather health information from people with early signs of gastric cancer, as well as healthy individuals and those already diagnosed, to better understand what might lead to this type of cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT06370143 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a registry of participants with precursor lesions for gastric cancer, such as gastric atrophy, intestinal metaplasia, and dysplasia. It will also enroll normal controls and individuals diagnosed with gastric cancer to compare baseline characteristics. Participants will complete a questionnaire to gather health information relevant to gastric cancer risk. The study seeks to enhance understanding of the factors contributing to gastric cancer development.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 and older with a diagnosis of gastric atrophy, intestinal metaplasia, dysplasia, or those with a history of early gastric cancer who have been treated and are disease-free.
Not a fit: Patients with active malignancies or those who do not meet the eligibility criteria for gastric precursors or healthy controls may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention strategies and early detection methods for gastric cancer.
How similar studies have performed: Other studies have shown success in understanding gastric cancer through similar observational approaches, indicating potential for valuable insights.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All protocol activites) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Limited Protocol Activites) — Rockville Centre, New York, United States (Recruiting)
Study contacts
- Principal investigator: Monika Laszkowska, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Monika Laszkowska, MD
- Email: LaszkowM@mskcc.org
- Phone: 212-639-6857
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.