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This is a research study for patients who currently have or previously had an H. pylori infection or who have gastric or esophageal cancer and who plan to undergo an endoscopy as part of their care. The purpose of this study is to find out how and why H. pylori infections can cause progression to gastric cancer and if it's possible for intervention prior to this progression.
H. pylori infection is a prevalent environmental cause of gastric cancer. The molecular mechanisms of carcinogenesis due to H. pylori remain unexplained and consequences of infection are variable and unpredictable. The aim of this research is to examine the RNA transcriptome of gastric cancer mucosa (gastric mucosa is the mucus membrane of the stomach), in patients with H. pylori infection and examine the spectrum of disease associated with infection. We will also examine bacterial content of samples to pinpoint the specific H. pylori strain(s) and the stomach microbial profile to correlate with the gastric mucosal transcriptome and predisposition of gastric cancer. Patients with prior or current active H. pylori infection who are planning to under endoscopic evaluation will be eligible for participation. From these patients, we plan to take up to four additional biopsies from each area of stomach already being sampled.
The biopsies will be used for next-generation RNA and DNA sequencing and novel bioinformatics analyses. The analysis will be performed at Weill Cornell Medical College by Doron Betel, PhD. The sequencing will be performed in the Epigenetics Core laboratory under the supervision of Doron Betel, who will be working closely with the principal investigator, Manish A. Shah, M.D. Examination of the genetic impact of H. pylori infection in patients may expose genetic factors that influence gastric cancer carcinogenesis and give deeper insight into molecular pathways that serve as candidate biomarkers for gastric cancer carcinogenesis. Our goal is to distinguish patients with chronic H. pylori infection who are at risk of subsequently developing gastric cancer from the vast majority of patients with H. pylori infection who do not develop malignancy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient | Subjects for this study will be either H. pylori positive with an active infection, cleared of an H. pylori infection or be both H. pylori antibody positive and have a malignancy of the gastrointestinal tract, specifically gastric adenocarcinoma. |
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| Control | A small subset of patients without H. pylori infection will be enrolled as well (n=30) to serve as a control group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopy tissue collection | Procedure | The investigational part of this study is the requirement for an additional biopsy from a site that is already being biopsied at the time of a routine endoscopy. Any patients who develop bleeding following their routine clinical biopsies will not undergo any additional research biopsies. |
| Measure | Description | Time Frame |
|---|---|---|
| Identify genomic alterations associated with H. pylori infection | Ability to obtain adequate tissue for next generation sequencing from endoscopy | Within 3 years of tissue collection |
| Measure | Description | Time Frame |
|---|---|---|
| Examine bacterial content in samples | High-throughput DNA and RNA sequencing will be used to determine bacterial content of samples | at time of sample collection |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects for this study will be either H. pylori positive with an active infection, cleared of an H. pylori infection or be both H. pylori antibody positive and have a malignancy of the gastrointestinal tract, specifically gastric adenocarcinoma. Of note, a small subset of patients without H. pylori infection will be enrolled as well (n=30) to serve as a control group.
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| Name | Affiliation | Role |
|---|---|---|
| Manish Shah, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical College | New York | New York | 10021 | United States |
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To examine RNA tranome of gastric cancer mucosa, in patients with H. pylori infection & examine spectrum of disease associated with infection. We will also examine bacterial content of samples to pinpoint specific H. pylori strain(s) & stomach microbial profile to correlate with gastric mucosal tranome & predisposition of gastric cancer. We plan to take 2-3 additional biopsies from an area of stomach already being sampled. The biopsies will be used for next-generation RNA & DNA sequencing & novel bioinformatics analyses. Examination of the genetic impact of H. pylori infection in patients may expose genetic factors that influence gastric cancer carcinogenesis & give deeper insight into molecular pathways that serve as candidate biomarkers for gastric cancer carcinogenesis.
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