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NCT00081354 · ClinicalTrials.gov registry record

Early Detection of Barrett's Esophagus

A clinical trial, sponsored by National Cancer Institute (NCI).

Completed
Registry status
737
Enrollment target

NCT00081354: Completed study, sponsored by National Cancer Institute (NCI).

NCT00081354 is a clinical trial that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 737 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00081354 has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
737 participants
Enrollment target

Study Summary

Background: The incidence rate for esophageal adenocarcinoma (EAC) has risen 10% per year over the past two decades and is the most rapidly increasing cancer in the U.S. Barrett's esophagus (BE), a metaplastic change from the normal squamous esophageal epithelium to a specialized intestinal-type columnar mucosa, increases the risk of EAC by 30-125, and is considered a precursor lesion for EAC. Individuals diagnosed with BE are currently entered into endoscopic surveillance programs to look for dysplasia or EAC. However, only 5% of subjects diagnosed with EAC have a previous diagnosis of BE or have been part of a surveillance program, so alternative screening methods are needed. Objectives: The primary goal of this project is to identify a practical blood-based biomarker(s) that can be used as a screening test to determine who has BE and who does not. Secondary goals of the project are to characterize germ-line and tissue biomarkers associated with BE, and to compare biomarkers in non-BE patients with and without GERD. Tertiary goals are to explore associations between biomarkers in blood or tissue and progression from BE to dysplasia or EAC, and to assess the stability of proteomic patterns over time. Eligibility: This study will be conducted among patients in the Barrett's Esophagus Registry (currently with 206 registrants) established at the National Naval Medical Center (NNMC) in Bethesda beginning in 1992, as well as a comparison group of approximately 600 matched non-BE patients endoscoped in the GI clinic at NNMC for other conditions. Design: Blood and tissue samples will be collected as well as questionnaire data on risk factors and medications as well as GERD. Data analyses will be based primarily on laboratory testing of newly collected esophageal biopsies, brush samples, and blood samples, but secondarily will also include use of archival tissue biopsy samples. Follow up of BE Registry patients will include standard periodic surveillance endos

Trial Details

FieldValue
Enrollment Target 737 participants
Start Date 2004-04-06
Est. Completion 2020-05-21
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00081354 record still lists

NCT00081354 is an observational study that tracks outcomes without assigning an intervention. The registered 737 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 0 interventions.

NCT00081354 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00081354 about?

NCT00081354 is a clinical study titled "Early Detection of Barrett's Esophagus". Background: The incidence rate for esophageal adenocarcinoma (EAC) has risen 10% per year over the past two decades and is the most rapidly increasing cancer in the U.S. Barrett's esophagus (BE), a metaplastic change from the normal squamous esophageal epithelium to a specialized intestinal-type c...

What is the current status of trial NCT00081354?

This trial is currently completed. The enrollment target is 737 participants. The study started on 2004-04-06. Estimated completion is 2020-05-21.

Who is sponsoring clinical trial NCT00081354?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00081354, the US trial registry maintained by the National Library of Medicine. NCT00081354 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.