Clinical trial NCT04880044: Detection of Barrett s Esophagus in Patients Without GERD Symptoms
Official title: Detection of Barrett s Esophagus in Patients Without Gastroesophageal Reflux Disease (GERD) Symptoms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Barrett's Esophagus
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2021-05-10
Enrollment: 500
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of this study is to develop a method to detect Barrett's esophagus (BE) in individuals with a new office-based diagnostic test.

Detailed description: This study will investigate whether using EsoCheck/EsoGuard(EC/EG) can detect BE in individuals at risk for BE who are currently not being detected and are not undergoing routine esophago-gastro-duodenoscopy (EGD)

BE can only be diagnosed by performing upper endoscopy. Up to 500 adults who have risk factors for BE but do not have chronic heartburn or regurgitation will be enrolled in this study. This will include the EsoCheck/EsoGuard determination along with the upper endoscopy for qualifying EsoGuard negative subjects

Eligibility 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

Primary outcomes:
measure: Positive predictive value (PPV) of EC/EG in a non-GERD population that has three or more non-GERD risk factors for BE.
timeFrame: Up to 2 months
measure: Proportion of participants negative via EC/EG who subsequently are proven negative via EGD
timeFrame: Up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
name: Amitabh Chak, MD
role: PRINCIPAL_INVESTIGATOR
References: