A Study Collecting Health Information to Understand and Prevent Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

Gastric Cancer Prevention: Understanding Precursor Lesions and Risk Factors for Progression to Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06370143
• Other study ID #: 24-083
• Status: Recruiting
• Start date: April 11, 2024
• Est. completion date: April 11, 2036

Study information

• Verified date: May 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Monika Laszkowska, MD
• Phone: 212-639-6857
• Email: LaszkowM[@]mskcc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3200
• Est. completion date: April 11, 2036
• Est. primary completion date: April 11, 2036
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Adenocarcinoma
• Atrophy
• Dysplasia
• Gastric Adenocarcinoma
• Gastric Atrophy
• Gastric Cancer
• Gastric Intestinal Metaplasia
• Gastritis, Atrophic
• Metaplasia
• Stomach Neoplasms

Intervention

Behavioral:
• Questionnaire
The questionnaire on clinical, environmental, lifestyle, and dietary risk factors will be administered

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)	Commack	New York
United States	Memorial Sloan Kettering Westchester (Limited Protocol Activities)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (All Protocol Activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Limited Protocol Activities)	Montvale	New Jersey
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

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center