Investigating how H. pylori infections may lead to gastric cancer
Next-Generation Sequencing to Evaluate Transcriptomic Changes Associated With H. Pylori Infection and Gastric Cancer Carcinogenesis
This study is trying to understand how H. pylori infections might lead to stomach cancer by looking at tissue samples from patients who have had these infections or have stomach or esophageal cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT02164409 on ClinicalTrials.gov |
What this trial studies
This research focuses on patients with current or past H. pylori infections, as well as those with gastric or esophageal cancer, who are scheduled for an endoscopy. The study aims to explore the molecular mechanisms by which H. pylori may contribute to gastric cancer development by analyzing RNA transcriptomes and bacterial content from gastric mucosa samples. Up to four additional biopsies will be collected for next-generation sequencing and bioinformatics analysis to identify genetic factors influencing cancer progression. The research is conducted at Weill Cornell Medical College under the supervision of experienced researchers.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with active or prior H. pylori infections or those diagnosed with gastric or esophageal cancer who are undergoing endoscopy.
Not a fit: Patients with recent upper GI bleeding, bleeding disorders, or recent strokes or heart attacks may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the genetic factors that influence the progression of gastric cancer, potentially leading to preventive interventions.
How similar studies have performed: While the investigation of H. pylori's role in gastric cancer is established, the specific molecular analysis approach in this study may provide novel insights, making it a potentially unique contribution to the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient must be 18 years or older * Patient must have active or prior H. pylori infection, or have been treated for H.pylori infection in the past, as assessed by ELISA (not applicable for the subset of patient controls) or have gastric or esophageal cancer or have Barrett's Esophagus * Patients must be eligible for and are planning to undergo a routine upper endoscopy and tissue biopsy * Patients must sign informed consent Exclusion Criteria: * Prior history of upper GI bleed (within 3 months) * Bleeding disorder or coagulopathy * Recent stroke or myocardial infarction (within 3 months)
Where this trial is running
New York, New York
- Weill Cornell Medical College — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Manish Shah, MD — Weill Medical College of Cornell University
- Study coordinator: Casey Owens, MPH
- Email: cdo4001@med.cornell.edu
- Phone: 646-962-3541
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.