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NCT06370143 | RECRUITING | Gastric Atrophy

A Study Collecting Health Information to Understand and Prevent Gastric Cancer
Sponsor:

Memorial Sloan Kettering Cancer Center

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.

Condition or disease

Gastric Atrophy

Gastric Intestinal Metaplasia

Dysplasia

Gastric Adenocarcinoma

Gastric Cancer

Intervention/treatment

Questionnaire

Study Type : OBSERVATIONAL
Estimated Enrollment : 3200 participants
Official Title : Gastric Cancer Prevention: Understanding Precursor Lesions and Risk Factors for Progression to Cancer
Actual Study Start Date : 2024-04-11
Estimated Primary Completion Date : 2036-04-11
Estimated Study Completion Date : 2036-04-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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.
A Study Collecting Health Information to Understand and Prevent Gastric Cancer

Location Details

NCT06370143

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New Jersey

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States, 07920

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States, 07748

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States, 07645

RECRUITING

United States, New York

Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)

Commack, New York, United States, 11725

RECRUITING

United States, New York

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States, 10604

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center (All protocol activites)

New York, New York, United States, 10065

RECRUITING

United States, New York

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York, United States, 11553