Primary Objective: The Primary Objective of the Study is to Evaluate the Acceptability and Feasibility of EGD-SC
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Acceptability and feasibility of EGD-SC measured by Linear Scale
研究概览
简要总结
Screening esophagogastroduodenoscopy (EGD )provides three distinct opportunities to decrease gastric cancer (GC) morbidity and mortality. has potential to discover cancer in early stages before the onset of symptoms, leading to higher rates of survival. Second, premalignant lesions such as adenomatous polyps, intestinal metaplasia and dysplasia can be discovered and removed with local resection, akin to polypectomies during screening colonoscopies, preventing the development of cancer. Third, EGD discovery and treatment of active Helicobacter pylori (HP) infection of the stomach provides an opportunity for primary prevention of GC.
详细描述
The primary objective of the study is to evaluate the acceptability and feasibility of EGD-SC.
The secondary objectives are:
- Estimate Median added time needed for EGD at the time of routine screening colonoscopy
- Estimate the frequencies of adverse events
- Estimate the percentage of pre-cancer and cancerous lesions including H. pylori infection, chronic atrophic gastritis, IM, dysplasia and GC among this high GC risk population
- Investigate whether high-risk racial/ethnicity groups have different likelihood of uptake of EGD, and whether the likelihood is associated with patient beliefs, attitudes and knowledge of GC, perceptions of risk, motivators and barriers, and sociocultural factors, as well as patient preference and satisfaction with EGD-SC
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have provided signed informed consent for the trial
- •Aged =40 and =80 years at the time of informed consent
- •Not planned to undergo EGD and not had EGD in the last five years
- •Planned to undergo colonoscopy
- •Half of the recruited subjects will be from high-risk groups
- •Willing and able to comply with all aspects of the protocol
排除标准
- •Persons with total gastrectomy
- •Persons with anatomic alteration that precludes EGD
- •Medical conditions that substantially increase risks for EGD
- •Had EGD in the last five years
研究组 & 干预措施
EGD at time of routine screening colonoscopy
This happens on Day 0. Screening for EGD, biopsy samples from esophagus, stomach, gastrointestinal junction, and duodenum AE's.
干预措施: esophagogastroduodenoscopy (EGD) (Procedure)
结局指标
主要结局
Acceptability and feasibility of EGD-SC measured by Linear Scale
时间窗: Pre-Study Screening Day -30 to day0
To achieve the goal of assessing feasibility of EDG-SC as well as estimates of effect size needed to determine sample size and power for the planned study, the investigator will collect data on the number of participants contacted, number eligible, and number who agree to EGD-SC.
次要结局
- Number of participants with AE's will be measured by the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 5.0(From the time of consent to through five calendar days after screening/treatment)
研究者
Haejin In
Surgical Oncology Associate Professor of Surgery
Rutgers, The State University of New Jersey