Clinical trial NCT06370143: A Study Collecting Health Information to Understand and Prevent Gastric Cancer
Official title: Gastric Cancer Prevention: Understanding Precursor Lesions and Risk Factors for Progression to Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Atrophy
Gastric Intestinal Metaplasia
Dysplasia
Gastric Adenocarcinoma
Gastric Cancer
Keywords: Gastric cancer
gastric adenocarcinoma
gastric atrophy
Gastric Intestinal Metaplasia
dysplasia
Memorial Sloan Kettering Cancer Center
24-083
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 3200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan Kettering (MSK).

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Creation of participant registry
timeFrame: Up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (All Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All protocol activites)
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activites)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Monika Laszkowska, MD
role: PRINCIPAL_INVESTIGATOR
References: