A Study to See if Collecting Cells with a Brush Will Have a Better Rate of Finding Cancer Cells in the Esophagus
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Sponsor Protocol Number: 13-006830
About this study
The purpose of this study is to see if collecting cells from the lining of the esophagus with a brush in addition to the biopsies taken for standard medical care will have a better rate of finding cancer cells related to having Barrett's esophagus.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Age: ≥ 18 years
- Should have a history of Barrett’s esophagus (with or without dysplasia of either indefinite, low grade or high-grade)
- Willingness to undergo both WATS and forceps biopsies while undergoing conventional EGD with sedation
- Ability to provide written, informed consent (approved by IRB) and understand the responsibilities of trial participation
- Only patients who undergo both forceps biopsies and WATS of the esophagus will be included in this study
Exclusion Criteria
- Coagulopathy with INR > 2.0, thrombocytopenia with platelet counts < 50,000
- Is pregnant or planning a pregnancy during the study period
- History of esophageal, gastric surgery
- Has undergone ablative therapies
- Has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines
- Patients with inadequate specimens will not undergo a repeat brush biopsy test and will be excluded from the study
- BE length < 1 cm or > 10 cm
- Any polypoid/ulcerated lesion > 10mm concerning for invasive cancer on endoscopy
- Visible lesions that are either submucosal or covered with a clinically intact epithelium
More information
Publications
Publications are currently not available