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临床试验/NCT01572974
NCT01572974终止不适用

Quality of Life in Barrett's Esophagus and GERD:GERD Symptoms, Perception of Cancer Risk, and Actual Cancer Risk

Midwest Biomedical Research Foundation1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
89
试验地点
1
主要终点
Health State Utility as measured by the Time Trade-off (TTO) method/Standard Gamble (SG) method

研究概览

简要总结

To Compare the overall quality of life of patients with no Barrett's esophagus , non-dysplastic Barrett's Esophagus (NDBE), Barrett's esophagus with low grade dysplasia (LGD), and Barrett's esophagus with high grade dysplasia (HGD). We also Compare the overall quality of life of Barrett's esophagus patients with severe gastroesophageal reflux disease (GERD) symptoms to those with no GERD symptoms

详细描述

The presence of GERD symptoms is associated with a significant decrease in quality of life.While a diagnosis of Barrett's esophagus is also associated with a decrease in quality of life, these studies evaluated Barrett's esophagus patients with GERD symptoms.It is unclear whether decrements in quality of life from cancer risk in patients with Barrett's esophagus are due to actual cancer risk or a patient's false perception.Here we Compare the overall quality of life of patients with no Barrett's esophagus , non-dysplastic Barrett's Esophagus (NDBE), Barrett's esophagus with low grade dysplasia (LGD), and Barrett's esophagus with high grade dysplasia (HGD). The Investigators will also Compare the overall quality of life of Barrett's esophagus patients with severe gastroesophageal reflux disease (GERD) symptoms to those with no GERD symptoms. Finally the investigators will compare the overall quality of life of patients with a perceived low risk of esophageal cancer to those with a perceived high risk of esophageal cancer

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Age 18 or above
  • At least one of the following:
  • Previous diagnosis of Barrett's esophagus Presence of GERD symptoms per patient report

排除标准

  • 未提供

结局指标

主要结局

Health State Utility as measured by the Time Trade-off (TTO) method/Standard Gamble (SG) method

时间窗: 1 year

questionnaire

次要结局

  • SF-36 physical function (PF) subscale(12 months)
  • SF-36 role limitations-physical (RP) subscale(12 months)
  • SF-36 general health (GH) subscale(12 months)

研究者

发起方
Midwest Biomedical Research Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

PRATEEK SHARMA

Principal Investigator

Midwest Biomedical Research Foundation

研究点 (1)

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