Recruiting

Observational Study

Sponsor:

Midwest Biomedical Research Foundation

Code:

NCT00574327

Conditions

Barrett's Esophagus

Gastroesophageal Reflux Disease

Esophageal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

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.

Conditions

Barrett's Esophagus

Gastroesophageal Reflux Disease

Esophageal Adenocarcinoma

Study ID

NCT00574327

Start date

Jan, 2006

Status verified date

Mar, 2023

Completion date

Jan, 2029

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

All patients must be eligible for care that the Kansas City VA Hospital where this study was approved for enrollment.

Inclusion Criteria:

  • Kansas City VA Patients with confirmed BE with and without dysplasia and patients with reflux disease (patients/cases); patients with other indicators for endoscopy such as anemia, weight loss, diarrhea, but without GERD and PE (controls).

Exclusion Criteria:

  • Patients with uncontrolled significant comorbidities such as cardiovascular, pulmonary, renal, hepatic or metabolic diseases.
  • Presence of anticoagulation that would increase risk from biopsies
  • Patients unable to provide history
  • Patients with dyspepsia

Study Design

Enrollment

3000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

B- gastroesophageal reflux subjects

Patients undergoing endoscopy for evaluation of GERD symptoms.

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 and Locations

Central contacts

April D Higbee, RN, BSN

816-861-4700april.higbee@va.gov

Carly Campbell, MS

816-861-4700Carlissa.Campbell@va.gov

Locations

Department of Veterans Affairs Medical Center

Recruiting

Kansas City, Missouri, United States, 64128

Principal Investigator:

Prateek Sharma, MD

More Information

Sponsor

Midwest Biomedical Research Foundation

Last update posted

Mar 16, 2023

Last verified

Mar, 2023

Keywords

  • Role
  • Registry
  • Barrett's Esophagus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Midwest Biomedical Research Foundation on 2023-03-16.