Progression of Gastroesophageal Reflux Disease and Barrett's Esophagus and the Creation of a Barrett's Registry

Part of paid clinical trials in Kansas City, Missouri.

Sponsor
Midwest Biomedical Research Foundation
Study ID
NCT00574327
Status
Recruiting
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Conditions

  • Barrett's Esophagus
  • Esophageal Adenocarcinoma
  • Gastroesophageal Reflux Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

The purpose of this study is to determine or evaluate the risk factors such as smoking, family history etc. that cause esophageal cancer and to determine the genetic changes that lead to esophageal cancer. The investigators hypothesis is that systematic collection of data on the natural history of GERD and BE patients and risk factors for development of BE in patients with chronic GERD and progression of BE to dysplasia and adenocarcinoma will provide useful information to develop a decision model for risk stratification and risk reduction strategies in these patients. As of March 17, 2011, 585 patients have consented at the Kansas City VA Medical Center.

Key Dates

Start date
Jan 31, 2006
Status verified
Mar 2023
Primary completion
Oct 31, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
3,000 participants (estimated)

Arms

  • Arm: A- Barrett's Esophagus subjects
    Patients with documented Barrett's Esophagus with or without dysplasia (LGD or HGD) that will undergo surveillance endoscopies dictated by the grade of dysplasia.
  • Arm: B- gastroesophageal reflux subjects
    Patients undergoing endoscopy for evaluation of GERD symptoms.
  • Arm: C-subjects without BE or GERD
    The control group would include patients undergoing upper endoscopy for reasons other than stated above, such as evaluation of iron deficiency anemia, weight loss, positive fecal occult blood, etc.

Primary Outcome Measure

The goal of this study is to follow GERD and BE pts prospectively for development of dysplasia and adenocarcinoma, to identify factors responsible for progression of GERD to BE to dysplasia and adenocarcinoma. [ Time Frame: 5 plus years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Department of Veterans Affairs Medical CenterKansas CityMissouri64128
Prateek Sharma, MD (PRINCIPAL_INVESTIGATOR)
Sharad Mathur, MD (SUB_INVESTIGATOR)
Prashant Pandya, DO (SUB_INVESTIGATOR)

Find similar trials in Kansas City, MO

By research site
Department of Veterans Affairs Medical Center· Kansas City, MO

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