Updated guidelines for the diagnosis, surveillance, and therapy of Barrett's esophagus.
Richard E Sampliner, Practice Parameters Committee of the American College of Gastroenterology
https://pubmed.ncbi.nlm.nih.gov/12190150Actively Recruiting
Age: 18Years +
All Genders
Healthy Volunteers
ID00574327
A Prospective Study to Define the Role of Factors in the Development and Progression of Gastroesophageal Reflux Disease and Barrett's Esophagus and the Creation of a Registry
Led by Midwest Biomedical Research Foundation · Updated on 2023-03-16
3000
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
M
Midwest Biomedical Research Foundation
Lead Sponsor
K
Kansas City Veteran Affairs Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to identify risk factors such as smoking and family history that contribute to esophageal cancer, focusing on patients with gastroesophageal reflux disease (GERD) and Barrett's esophagus (BE). The study seeks to understand genetic changes leading to cancer and develop a decision model for risk stratification and reduction. GERD affects a large portion of adults, particularly older males, and BE is a known precursor to esophageal adenocarcinoma, which is rapidly increasing in incidence. The study is a prospective observational cohort conducted at the Kansas City VA Medical Center involving three groups: patients with Barrett's Esophagus (with or without dysplasia), patients with GERD symptoms undergoing endoscopy, and control patients undergoing endoscopy for other reasons. Participants will complete questionnaires on GERD severity, diet, medication, family, and social history. Medical records will be reviewed for relevant findings, and blood and tissue samples will be collected for biomarker and genetic studies. Participants will be followed for over five years to monitor the progression from GERD to BE, dysplasia, and adenocarcinoma. Researchers will collect clinical data, pathology reports, and biospecimens to study disease progression and identify risk factors. The study also aims to build a tissue and serum repository for future research. The total participation time and safety monitoring details are based on ongoing routine surveillance endoscopies and clinical follow-up.
CONDITIONS
Brief Title
Progression of Gastroesophageal Reflux Disease and Barrett's Esophagus and the Creation of a Barrett's Registry
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Patients eligible for care at the Kansas City VA Hospital
- Patients with confirmed Barrett's Esophagus with or without dysplasia
- Patients with gastroesophageal reflux disease (GERD)
- Patients undergoing endoscopy for other reasons such as anemia, weight loss, or diarrhea without GERD or Barrett's Esophagus
You will not qualify if you...
- Patients with uncontrolled significant cardiovascular, pulmonary, renal, hepatic, or metabolic diseases
- Patients taking anticoagulants that increase risk from biopsies
- Patients unable to provide medical history
- Patients with dyspepsia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surveillance
Duration - 5 plus years
Participants are monitored over time to observe the development and progression of gastroesophageal reflux disease (GERD) and Barrett's Esophagus (BE), including collection of questionnaires, medical history, and biological samples.
Surveillance visits as dictated by clinical need and grade of dysplasia for participants with Barrett's Esophagus
Trial Site Locations
Total: 1 location
1
Department of Veterans Affairs Medical Center
Kansas City, Missouri, United States, 64128
Actively Recruiting
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Research Team
A
April D Higbee, RN, BSN
C
Carly Campbell, MS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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Published Research Related To This Trial
Barrett's esophagus, dysplasia, and adenocarcinoma.
R C Haggitt
https://pubmed.ncbi.nlm.nih.gov/7927321Barrett's esophagus and esophageal adenocarcinoma.
B J Reid
https://pubmed.ncbi.nlm.nih.gov/1787015Impact of endoscopic biopsy surveillance of Barrett's oesophagus on pathological stage and clinical outcome of Barrett's carcinoma.
J W van Sandick, J J van Lanschot, B W Kuiken...
https://pubmed.ncbi.nlm.nih.gov/10189847A majority of patients with Barrett's oesophagus are unlikely to benefit from endoscopic cancer surveillance.
S Gudlaugsdottir, M van Blankenstein, J Dees...
https://pubmed.ncbi.nlm.nih.gov/11434588Oesophageal cancer is an uncommon cause of death in patients with Barrett's oesophagus.
A van der Burgh, J Dees, W C Hop...
https://pubmed.ncbi.nlm.nih.gov/8881798The incidence of adenocarcinoma and dysplasia in Barrett's esophagus: report on the Cleveland Clinic Barrett's Esophagus Registry.
J B O'Connor, G W Falk, J E Richter
https://pubmed.ncbi.nlm.nih.gov/10445525Epidemiologic risk factors for Barrett's esophagus and associated adenocarcinoma.
Angela Wong, Rebecca C Fitzgerald
https://pubmed.ncbi.nlm.nih.gov/15645398Cyclooxygenase 2 expression in Barrett's esophagus and adenocarcinoma: Ex vivo induction by bile salts and acid exposure.
V N Shirvani, R Ouatu-Lascar, B S Kaur...
https://pubmed.ncbi.nlm.nih.gov/10702199Increased expression of inducible nitric oxide synthase and cyclooxygenase-2 in Barrett's esophagus and associated adenocarcinomas.
K T Wilson, S Fu, K S Ramanujam...
https://pubmed.ncbi.nlm.nih.gov/9679948