Understanding the progression of Barrett's Esophagus and its risk factors
A Prospective Study To Define The Role Of Various Factors In Development And Progression Of Gastroesophageal Reflux Disease (GERD) And Barrett's Esophagus And The Creation Of A Registry.
This study looks at how certain factors might affect the progression of GERD and Barrett's Esophagus to see who is at higher risk for serious issues like cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Midwest Veterans' Biomedical Research Foundation Academic / other |
| Locations | 1 site (Kansas City, Missouri) |
| Trial ID | NCT00574327 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the risk factors associated with the progression of gastroesophageal reflux disease (GERD) and Barrett's Esophagus (BE), including genetic changes that may lead to esophageal cancer. By systematically collecting data on the natural history of GERD and BE patients, the study seeks to identify those at increased risk for developing dysplasia and adenocarcinoma. The findings could inform decision models for risk stratification and strategies for risk reduction in affected patients.
Who should consider this trial
Good fit: Ideal candidates include patients at the Kansas City VA with confirmed Barrett's Esophagus, those with chronic GERD, and individuals with other indicators for endoscopy.
Not a fit: Patients with uncontrolled significant comorbidities or those unable to provide a medical history may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved screening and surveillance strategies for patients at risk of esophageal cancer.
How similar studies have performed: Other studies have shown success in identifying risk factors for Barrett's Esophagus and esophageal cancer, making this approach both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
All patients must be eligible for care that the Kansas City VA Hospital where this study was approved for enrollment. Inclusion Criteria: * Kansas City VA Patients with confirmed BE with and without dysplasia and patients with reflux disease (patients/cases); patients with other indicators for endoscopy such as anemia, weight loss, diarrhea, but without GERD and PE (controls). Exclusion Criteria: * Patients with uncontrolled significant comorbidities such as cardiovascular, pulmonary, renal, hepatic or metabolic diseases. * Presence of anticoagulation that would increase risk from biopsies * Patients unable to provide history * Patients with dyspepsia
Where this trial is running
Kansas City, Missouri
- Department of Veterans Affairs Medical Center — Kansas City, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Prateek Sharma, MD — Department of Veterans Affairs Medical Center of Kansas City
- Study coordinator: April D Higbee, RN, BSN
- Email: april.higbee@va.gov
- Phone: 816-861-4700
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.