Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma
报名条件（概要）
- 年龄：18 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
United States
药品与企业信息
其他名称：Esophageal Sampling Device BESD-001
The Esophageal Sampling Device BESD-001 is a non-endoscopic balloon capsule catheter for obtaining an esophageal mucosal sample. At the distal end of the catheter there is a silicone capsule textured balloon assembly. The textured balloon is initially inverted with vacuum for patient to swallow the capsule but then is inflated with 5.6 cc of air (5 cc syringe withdrawn maximally) to a 16-18 mm diameter in order to contact the lumen of the esophagus to collect a sample. The balloon has a textured surface, which enhances the collection of the esophageal sample. Following sample collection the textured balloon is inverted back into the hollow capsule component via syringe draw vacuum in order to maximize \& protect the site-specific sample collection.
其他名称：EGD
An upper endoscopy is a procedure used to visually examine your upper digestive system with a tiny camera on the end of a long, flexible tube.
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。
合作机构
- University Hospitals Cleveland Medical Center研究机构/其他
- Washington University School of Medicine研究机构/其他
- Fred Hutchinson Cancer Center研究机构/其他
- University of Washington研究机构/其他
- Mercy Medical Center研究机构/其他
- Johns Hopkins University研究机构/其他
- Mayo Clinic研究机构/其他
- University of North Carolina, Chapel Hill研究机构/其他
- The Cleveland Clinic研究机构/其他
- University of Pennsylvania研究机构/其他
- Columbia University研究机构/其他
- VA Puget Sound Health Care System政府机构
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 overall objectives of this BETRNet Research Center (RC) are: 1. to conduct a rigorous, integrated spectrum of transdisciplinary human research in Barrett's esophagus (BE) and esophageal adenocarcinoma (ECA) 2. to increase the biological understanding of key observations made by our clinical researchers; 3. to translate knowledge derived from genetic, epigenetic, and transcriptome research to solving clinical dilemmas in detection, prognosis, prevention, and therapy of BE in order to prevent EAC and improve the outcomes of EAC; 4. to foster a transdisciplinary and translation research culture and to effectively expand and enhance scientific research focused on BE and EAC; 5. to evaluate research and transdisciplinary programs and to continuously improve research, productivity and enhance translational implementation. These objectives build and synergize on existing multi-institutional collaborative networks and the considerable clinical, basic science, and translational expertise available at our institutions, focusing on improving the outcomes of patients with BE and EAC. The overarching organization framework for this RC proposal is 1) to focus laboratory research on understanding the genetic susceptibility, genomic and epigenetic changes that influence the development of BE and EAC; and 2) to then translate laboratorydiscoveries into clinical applications for effective detection, molecular risk stratification, and prevention of progression from BE to EAC.
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）
- Amitabh Chak, MDaxc22@po.cwru.edu216-844-5385
- Wendy Brock, RNwendy.brock@UHhospitals.org216-844-3853
研究中心联系方式
- Johns Hopkins HospitalBaltimore，Maryland，United States
- Mayo ClinicRochester，Minnesota，United States
- Washington University School of MedicineSt Louis，Missouri，United States
- Columbia University Medical CenterNew York，New York，United States
- University of North Carolina at Chapel HillChapel Hill，North Carolina，United States
- University Hospitals of ClevelandCleveland，Ohio，United States
问自己是否符合条件、如何预筛
我的病情档案
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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: Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma ClinicalTrials.gov Identifier: NCT00288119 Sponsor: Case Western Reserve University Investigational product: Balloon Capsule Device, Endoscopy 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：Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma 试验编号：NCT00288119 申办方：Case Western Reserve University 研究药物：Balloon Capsule Device、Endoscopy 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）。