Review article: a conceptual approach to understanding the molecular mechanisms of cancer development in Barrett's oesophagus.
R F Souza, C P Morales, S J Spechler
https://pubmed.ncbi.nlm.nih.gov/11472311/Actively Recruiting
Led by Midwest Biomedical Research Foundation · Updated on 2023-03-16
3000
Participants Needed
1
Research Sites
13 weeks
Total Duration
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 Barretts 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 Barretts 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
Progression of Gastroesophageal Reflux Disease and Barrett's Esophagus and the Creation of a Barrett's Registry
A
April D Higbee, RN, BSN
C
Carly Campbell, MS
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Midwest Biomedical Research Foundation
Lead Sponsor
Kansas City Veteran Affairs Medical Center
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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https://pubmed.ncbi.nlm.nih.gov/8642813/Midwest Biomedical Research Foundation
Lead Sponsor
Kansas City Veteran Affairs Medical Center
Collaborating Sponsor