Barrett's Oesophagus Two Yearly Surveillance Versus Endoscopy at Need: a Randomised Controlled Trial to Estimate Effectiveness and Cost-effectiveness Study (BOSS)

Gloucestershire Hospitals NHS Foundation Trust2 个研究点分布在 1 个国家目标入组 3,400 人开始时间: 2009年3月最近更新: 2017年8月22日

适应症

干预措施

试验速览

阶段: 不适用
发起方: Gloucestershire Hospitals NHS Foundation Trust
入组人数: 3,400
试验地点: 2
主要终点: Overall survival

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

RATIONALE: Screening tests may help doctors find cancer cells early and plan better treatment. It is not yet known whether endoscopy every 2 years is more effective than endoscopy only as needed in finding esophageal cancer in patients with Barrett esophagus.

PURPOSE: This randomized phase III trial is studying endoscopy every 2 years to see how well it works compared with endoscopy only as needed in monitoring patients with Barrett esophagus.

详细描述

OBJECTIVES:

Primary

To establish whether endoscopic surveillance every 2 years or endoscopy at need only is superior in terms of overall survival and, if neither is superior, whether endoscopy at need only is non-inferior to surveillance every 2 years in patients with Barrett esophagus.

Secondary

To estimate the cost-effectiveness of endoscopic surveillance every 2 years as compared to endoscopy at need only.
To establish whether there is a significant difference between endoscopic surveillance every 2 years or endoscopy at need only in terms of the incidence of esophageal cancer, gastric or esophageal cancer, or all cancers.
To establish whether there is a significant difference between endoscopic surveillance every 2 years or endoscopy at need only in terms of the time to diagnosis of esophageal adenocarcinoma.
To establish whether there is a significant difference between endoscopic surveillance every 2 years or endoscopy at need only in terms of the stage of esophageal adenocarcinoma at diagnosis using TNM staging.
To establish whether there is a significant difference between endoscopic surveillance every 2 years or endoscopy at need only in terms of morbidity and mortality related to endoscopy, esophageal surgery, and other endoscopy-related interventions (e.g., ablation).
To establish whether there is a significant difference between endoscopic surveillance every 2 years or endoscopy at need only in terms of the frequency of endoscopy.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Screening
盲法: None

入排标准

年龄范围: 18 Years 至 120 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

未提供

研究组 & 干预措施

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干预措施: comparison of screening methods (Procedure)

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干预措施: endoscopic biopsy (Procedure)

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干预措施: diagnostic endoscopic procedure (Procedure)

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Two years endoscopies

干预措施: 2 yearly endoscopy (Procedure)

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Two years endoscopies

干预措施: endoscopic procedure (Procedure)

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干预措施: quality-of-life assessment (Procedure)

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Two years endoscopies

干预措施: screening method (Procedure)