Detecting Barrett's Esophagus in Patients Without GERD Symptoms
Detection of Barrett s Esophagus in Patients Without Gastroesophageal Reflux Disease (GERD) Symptoms
This study is testing a new office-based test to find Barrett's esophagus in people over 50 who are at risk but don't have typical GERD symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT04880044 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a new office-based diagnostic test to detect Barrett's esophagus (BE) in individuals who are at risk but do not exhibit typical GERD symptoms. Up to 500 adults over the age of 50, with specific risk factors for BE, will be enrolled. Participants will undergo the EsoCheck/EsoGuard test along with an upper endoscopy for those who test negative for EsoGuard. The goal is to identify BE in patients who are currently undiagnosed and not receiving routine endoscopic evaluations.
Who should consider this trial
Good fit: Ideal candidates are adults over 50 with two or more risk factors for Barrett's esophagus but without chronic GERD symptoms.
Not a fit: Patients with a history of chronic GERD symptoms or those who have previously undergone an upper endoscopy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection of Barrett's esophagus, potentially reducing the risk of progression to esophageal cancer.
How similar studies have performed: While the approach of using office-based diagnostics for BE detection is innovative, similar studies have shown promise in identifying at-risk populations, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * No known coagulopathy, no known esophageal varices. * No significant dysphagia or odynophagia * Absence of chronic GERD, defined as five or more years of heartburn or regurgitation with symptoms at least once a week when not on medications for GERD symptoms. * Subjects to qualify must meet criterion 3, be over age 50, and have two additional risk factors for BE (white race, central obesity defined as waist size \>35 inches for women and \>40 inches for men, male gender, current smoker or smoking history \>10 pack years, confirmed family history in at least two members with one being a first degree relative). Exclusion Criteria: * History of prior EGD procedure * Inability to provide written informed consent * History of weekly of more frequent heartburn or regurgitation for five or more years * On anti-coagulant drug(s)that cannot be temporarily discontinued or coagulopathy with international normalized ratio (INR) \> 1.5 * Known history of esophageal varices or esophageal stricture * Any contraindication, as deemed inInvestigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGDprocedure,and/or having biopsies taken, including but not limited to due to comorbidities such as coagulopathy or a known history of esophageal diverticula, esophageal fistula and/or esophageal ulceration * History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills * Oropharyngeal tumor * History of esophageal or gastric surgery, with exception on uncomplicated surgical fundoplication procedure * History of myocardial infarction or cerebrovascular accident within past 6 months
Where this trial is running
Cleveland, Ohio
- University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Amitabh Chak, MD — University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
- Study coordinator: Amitabh Chak, MD
- Email: CTUReferral@UHhospitals.org
- Phone: 1-800-641-2422
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.