Screening At-risk Populations for Hepatic Fibrosis With Non-invasive Markers
报名条件(概要)
- 年龄:30 Years – 75 Years
- 性别:不限
- 健康志愿者:不接受
完整入排标准请以官方页面为准。
开展国家/地区
Denmark
药品与企业信息
其他名称:FibroScan、TE
Ultrasound elastography using shear-wave elastography to measure liver stiffness as a marker of liver fibrosis. Patients with transient elastography above 8.0 kPa selected for liver biopsy to detect advanced liver fibrosis
其他名称:ELF
Patented, commercially available algorithm of hyaluronic acid (HA), N-terminal propeptide of collagen type 3 (P3NP) and tissue inhibitor of metalloproteinase 1 (TIMP-1)
其他名称:Forns index、FIB-4、APRI、AST-ALT ratio、Age-platelet ratio
Diagnostic markers using combination of routine liver biochemistry: age, AST, ALT, platelet count, cholesterol, GGT
其他名称:Neoepitopes、Collagen products、Extracellular matrix
Serum markers that reflect liver extracellular matrix turnover and -accumulation
Software that contain 199 diagnostic algorithms, containing combinations of routine tests: age, AST, albumin, alkaline phosphatase, bilirubin, GGT, INR, platelet count, cholesterol and sodium, and specialist tests: transient elastography and direct serum markers of fibrosis.
其他名称:CK18、M30、M65
Cytokeratin 18 from liver cell cytoskeleton; when cells undergo apoptosis, caspase-cleaved CK18 is released (M30), whereas full-length CK18 is realised during necrosis (M65)
其他名称:Multi-omics markers、Lipidomics、Microbiomics、Genomics、Metagenomics、Metatranscriptomics
Markers combining signatures of liver fibrosis and hepatic inflammation from many 'omics technologies
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
- Horizon 2020 - European Commission研究机构/其他
- Novo Nordisk A/S企业
- University of Southern Denmark研究机构/其他
- Esbjerg University Hospital of South-West JutlandUNKNOWN
- Odense Municipality Alcohol Rehabilitation UnitUNKNOWN
- Svendborg Municipality Alcohol Rehabilitation UnitUNKNOWN
- University of Copenhagen研究机构/其他
- University of Oslo研究机构/其他
- Nordic Bioscience A/S企业
- VLV Bio, Peviva ABUNKNOWN
- Manatee APSUNKNOWN
- Siemens Healthcare A/S企业
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)
Prospective screening study at Odense University Hospital to assess the effect of transient elastography and other serum and imaging markers of liver fibrosis to detect advanced fibrosis (Kleiner Fibrosis score F3-F4) in patients at risk of non-alcoholic fatty liver disease, alcoholic fatty liver disease, with a control group of participants recruited from the general population.
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)
- Maja Thiele, MD, PhD, Professormaja.thiele@rsyd.dk+4524998068
研究中心联系方式
- Department of Gastroenterology and Hepatology, Odense University HospitalOdense,Denmark
问自己是否符合条件、如何预筛
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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: Screening At-risk Populations for Hepatic Fibrosis With Non-invasive Markers ClinicalTrials.gov Identifier: NCT03308916 Sponsor: Maja Thiele Investigational product: transient elastography, Enhanced liver fibrosis test, Indirect serum markers of liver fibrosis, Direct serum markers of liver fibrosis, LiverTRAIL 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:Screening At-risk Populations for Hepatic Fibrosis With Non-invasive Markers 试验编号:NCT03308916 申办方:Maja Thiele 研究药物:transient elastography、Enhanced liver fibrosis test、Indirect serum markers of liver fibrosis、Direct serum markers of liver fibrosis、LiverTRAIL 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)。