A Study Collecting Health Information to Understand and Prevent Gastric Cancer

NCT06370143 — Recruiting, 3200 participants, Memorial Sloan Kettering Cancer Center

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

RegistryNCT06370143
StatusRecruiting
Study typeObservational
Enrollment3200 (Estimated)
SponsorMemorial Sloan Kettering Cancer Center (Other)
ConditionsGastric Atrophy, Gastric Intestinal Metaplasia, Dysplasia, Gastric Adenocarcinoma, Gastric Cancer
InterventionsQuestionnaire (Behavioral)
Datesstart 2024-04-11, primary completion 2036-04-11 (estimated), completion 2036-04-11 (estimated), first posted 2024-04-17, last updated 2026-01-30
Locations7 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Gastric Atrophy All trials for Gastric Intestinal Metaplasia All trials of Questionnaire

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Participants with atrophic gastritis, intestinal metaplasia, and dysplasiaBehavioral: QuestionnaireParticipants with presence of atrophic gastritis, intestinal metaplasia, and dysplasia and risk of the progression of these lesions
Control GroupBehavioral: QuestionnaireHealthy controls
Participants with gastric cancerBehavioral: QuestionnaireParticipants with gastric cancer
  • Questionnaire (Behavioral): The questionnaire on clinical, environmental, lifestyle, and dietary risk factors will be administered

+Outcome measures

Primary outcomes

  • Creation of participant registry [Up to 10 years]: 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.

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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.

+Locations (7)

FacilityCityCountryStatus
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)Basking Ridge, New JerseyUnited StatesRecruiting
Memorial Sloan Kettering Monmouth (All Protocol Activities)Middletown, New JerseyUnited StatesRecruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)Montvale, New JerseyUnited StatesRecruiting
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)Commack, New YorkUnited StatesRecruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)Harrison, New YorkUnited StatesRecruiting
Memorial Sloan Kettering Cancer Center (All protocol activites)New York, New YorkUnited StatesRecruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activites)Rockville Centre, New YorkUnited StatesRecruiting

+Investigators