Endoscopic Screening of Asymptomatic Patients for Helicobacter Pylori, Intestinal Metaplasia, and Barrett's Mucosa During Screening Colonoscopy
报名条件(概要)
- 年龄:30 Years – 不限
- 性别:不限
- 健康志愿者:接受
完整入排标准请以官方页面为准。
开展国家/地区
Austria
药品与企业信息
官方登记暂未公布具体药物或干预措施。
研发企业
试验官方登记的主要申办方;研究机构申办时会显示相应机构名称。
生产企业
公开药品批准资料或正式说明书暂未提供明确的生产企业信息。
研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业;生产企业仅取自美国上市原研药说明书所列企业(不含仿制药),不作推测;仅在其他国家上市的药品暂无法显示。
研究简介(原文)
The goal of this observational study is to learn how common Helicobacter pylori (H. pylori) infection is in adults without stomach or upper gastrointestinal symptoms who are having a preventive screening colonoscopy. Endoscopic screening of the stomach is yet not acceptet as a standard screening procedure in Western countries. However, Helicobacter pylori infection is known to increase the risk of developing gastric cancer. This study will look at the prevalence of Helicobacter pylori infection in asymptomatic patients who have an additional gastroscopy during the same session as their screening colonoscopy. It will also record other early tissue changes or risk factors for stomach cancer, such as intestinal metaplasia and Barrett's mucosa. The main questions this study aims to answer are: * How often is Helicobacter pylori found in adults without upper gastrointestinal symptoms by use of OGD? * Are there any correlations between H. pylori infection and other risk factors, such as BMI, smoking, alcohol consumption, or a family history of colorectal and/or stomach cancer? About 1000 participants are expected to take part. Adults undergoing a screening colonoscopy at a private endoscopy center will be offered the chance to have an additional gastroscopy if they meet the study's inclusion criteria (no previous Helicobacter pylori infection and no upper gastrointestinal symptoms). Small tissue samples (biopsies) will be taken from the stomach and lower esophagus during the gastroscopy. Biopsies will be checked histologically for the presence of Helicobacter pylori and early tissue changes. During the gastroscopy, no additional procedures or biopsies will be done beyond what is normally performed during a routine examination. Everything done during this procedure follows the standard steps of a regular gastroscopy. All data will be coded to protect participant privacy. Researchers will use statistical methods to find out how common Helicobacter pylori infection is and whether it is related to other lifestyle or family risk factors or tissue changes.
适应症
主动联系研究团队
这项试验目前在中国大陆没有研究中心
这种情况下,直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药/扩展准入(由主治医生一同提出),或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。
查看完整申请路径与成功率说明 →总联系人(申办方/研究总部)
- Harald Rosen, Univ. Prof. Dr.rosensurg@csi.com+43 664 4422571
研究中心联系方式
- Wiener Privatklinik (WPK)Vienna,Austria
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英文版(发给研究团队)
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: Endoscopic Screening of Asymptomatic Patients for Helicobacter Pylori, Intestinal Metaplasia, and Barrett's Mucosa During Screening Colonoscopy ClinicalTrials.gov Identifier: NCT07346521 Sponsor: Sigmund Freud PrivatUniversitat Investigational product: N/A About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照(供您核对)
尊敬的研究团队: 我是一位来自中国的患者,希望咨询参加以下临床试验的可能: 研究名称:Endoscopic Screening of Asymptomatic Patients for Helicobacter Pylori, Intestinal Metaplasia, and Barrett's Mucosa During Screening Colonoscopy 试验编号:NCT07346521 申办方:Sigmund Freud PrivatUniversitat 研究药物:未公布 我的基本情况: - 年龄:(请填写) - 性别:(请填写) - 确诊疾病与分期:(请填写) - 基因/标志物检测:暂无 - 既往及当前治疗:(请填写) - 体能状态(ECOG):未评估 - 目前所在城市:中国 - 可前往范围:(请填写) 想请教三个问题: 1. 我是否可能符合本研究的入组标准? 2. 哪个中心对我最方便可行?能否远程预筛? 3. 预筛需要准备哪些资料(病历、病理、影像、近期化验)? 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 (您的姓名) (您的邮箱/带国际区号的电话)
提示:请与主治医生一起发信——由医生署名的申请,回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复,两周无回音可礼貌追问一次。
下一步怎么做?
- 把本页信息带给您的主治医生,评估是否适合参加。
- 点击下方按钮打开官方注册页,查看研究中心联系方式。
- 直接联系研究团队咨询报名事宜(通常有中文同声翻译服务可协助沟通)。