Status:
TERMINATED
Rapid Assessment of Esophageal Adenocarcinoma Risk Test
Lead Sponsor:
Columbia University
Conditions:
Barrett Esophagus
Esophageal Adenocarcinoma
Eligibility:
All Genders
50-75 years
Phase:
NA
Brief Summary
This study aims to evaluate the acceptability of a new non-invasive screening device to test for Barrett's esophagus. The investigators will prospectively enroll 100 patients to undergo Cytosponge tes...
Detailed Description
The incidence of esophageal adenocarcinoma (EAC) has risen over the past half century and continues to have a dismal prognosis. Even though it has been established that Barrett's esophagus (BE) is the...
Eligibility Criteria
Inclusion
- Males:
- Ages 50-75 and at least one of the following:
- Gastro-esophageal reflux disease (GERD)\* or
- Family history (first degree relative) with Barrett's esophagus or esophageal adenocarcinoma or
- Both body mass index (BMI) ≥30 or
- A history of cigarette smoking (at least 10 pack years)
- Females:
- Ages 50-75 and GERD\* and at least one of the following:
- Family history (first degree relative) with Barrett's esophagus or esophageal adenocarcinoma or
- BMI ≥30 or
- A history of cigarette smoking (at least 10 pack years)
Exclusion
- History of gastric or esophageal cancer
- History of esophageal surgery
- Known untreated esophageal stricture or uninvestigated dysphagia
- Previous upper endoscopy within 10 years
- Cancer within 3 years except for non-melanoma skin cancer
- Portal hypertension, with or without known varices
- Uncontrolled coagulopathy
- Uncontrolled major comorbid illness
- Inability to tolerate or contraindication to upper endoscopy
- Inability to give informed consent
- GERD defined as either a history of frequent heartburn or fluid regurgitation symptoms (at least weekly for 6 months) or regular use of proton pump inhibitors or histamine-2 receptor antagonists.
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2023
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT03366012
Start Date
August 1 2018
End Date
May 19 2023
Last Update
November 8 2024
Active Locations (1)
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1
Columbia University Irving Medical Center
New York, New York, United States, 10032