Detecting Barrett's Esophagus in Patients Without GERD Symptoms
Multi-Site Detection of Barrett's Esophagus in Patients Without Chronic GERD Symptoms
This study is testing a new way to find Barrett's esophagus in people who don’t have GERD symptoms by using a simple capsule test instead of the usual endoscopy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Locations | 5 sites (Aurora, Colorado and 4 other locations) |
| Trial ID | NCT06687603 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to develop a non-endoscopic method for detecting Barrett's esophagus in individuals who do not exhibit chronic GERD symptoms. Participants will complete a questionnaire, undergo a capsule balloon test called EsoCheck, and have their samples analyzed using the EsoGuard test to identify Barrett's esophagus. The study seeks to address the high incidence of esophageal adenocarcinoma by improving screening methods, as current detection relies heavily on upper endoscopy, which is underutilized. The trial will recruit patients undergoing screening colonoscopy to evaluate the efficacy of this new diagnostic approach.
Who should consider this trial
Good fit: Ideal candidates are adults over 50 years old without GERD symptoms who are undergoing screening colonoscopy and have not had a prior endoscopy in the last ten years.
Not a fit: Patients with known GERD symptoms or those who have undergone an endoscopy in the past ten years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve early detection of Barrett's esophagus, potentially reducing the incidence of esophageal adenocarcinoma.
How similar studies have performed: Previous studies have shown success with similar non-endoscopic approaches for Barrett's esophagus detection, indicating potential for this method.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients undergoing screening colonoscopy are an accessible cohort for BE screening and are also a reasonable representation of the general population. Permission will be obtained from colonoscopy physicians for researchers to contact and recruit patients for this study. Patients without GERD, who are at risk for BE, and who have not had a prior EGD, will be recruited prior to or at the time of scheduled colonoscopy.(9) Those eligible will be: * Adults who have not had prior EGD within past ten years, and are able to provide informed consent, and who have: * No known coagulopathy, no known esophageal varices, not on chronic anticoagulation therapy, and have: * No significant dysphagia or odynophagia; but who do have: * Absence of GERD (absence of weekly heartburn or regurgitation, not on medications for GERD), and are: * Adults \> age 50, who also have two or more added risk factors for BE from the set of: central obesity (waist size \> 35 inches for women and \> 40 inches for men), current smoker or smoking history \> 10 pack years, white race, male sex, confirmed history of BE/EAC in at least two family members, with one a first degree relative. While BE is most highly prevalent in white males, a black female over age 50 with obesity and a positive smoking history would also be at increased BE risk and would equally meet eligibility criteria. * Subjects must have the ability to understand and the willingness to sign a written informed consent document. * Subjects must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * History of prior EGD procedure in past ten years * 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 INR \> 1.5 * Known history of esophageal varices or esophageal stricture * Any contraindication, as deemed in Investigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGD procedure, 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 of uncomplicated surgical fundoplication procedure
Where this trial is running
Aurora, Colorado and 4 other locations
- University of Colorado — Aurora, Colorado, United States (Recruiting)
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Not_yet_recruiting)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
- Cleveland Clinic Taussig Cancer Center — Cleveland, Ohio, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Amitabh Chak, MD — University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
- Study coordinator: Wendy Brock
- Email: Wendy.brock@uhhospitals.org
- Phone: 216-844-3853
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.