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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06370143
Other study ID # 24-083
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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)

Study Design


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
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