|

A Study Collecting Health Information to Understand and Prevent Gastric Cancer

RECRUITINGSponsored by Memorial Sloan Kettering Cancer Center
Actively Recruiting
SponsorMemorial Sloan Kettering Cancer Center
Started2024-04-11
Est. completion2036-04-11
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations7 sites

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

Age: 18 Years+Healthy volunteers accepted
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.

Conditions6

CancerDysplasiaGastric AdenocarcinomaGastric AtrophyGastric CancerGastric Intestinal Metaplasia

Locations7 sites

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Monika Laszkowska, MD212-639-6857
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Monika Laszkowska, MD212-639-6857
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Monika Laszkowska, MD212-639-6857
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York, 11725
Monika Laszkowska, PhD212-639-6857
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Monika Laszkowska, MD212-639-6857

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.