Multi-Site Detection of Barrett's Esophagus in Patients Without Chronic GERD Symptoms

Launched by CASE COMPREHENSIVE CANCER CENTER · Nov 12, 2024

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ClinConnect Summary

This clinical trial is focused on finding a new way to detect Barrett's esophagus, a condition where the lining of the esophagus is damaged due to acid reflux. The trial is specifically looking at patients who do not have chronic symptoms of gastroesophageal reflux disease (GERD). Researchers want to determine if a new office-based test can effectively screen for Barrett's esophagus in individuals at risk. This is important because Barrett's esophagus can lead to a more serious condition called esophageal adenocarcinoma, a type of cancer.

To participate in this study, you need to be an adult over 50 years old with certain risk factors, such as obesity or a history of smoking, and you should not have had any previous endoscopies in the last ten years. Participants will complete a questionnaire, undergo a simple capsule balloon test called EsoCheck, and have samples sent to a lab for further testing. Additionally, participants will have a standard upper endoscopy, which is a procedure that allows doctors to look inside your esophagus. If you're interested and meet the eligibility criteria, this trial could be a valuable opportunity to help improve the detection of Barrett's esophagus.

Gender

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Eligibility 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