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正在招募不适用编号 NCT07899502

REAL-MS: Observational Database Study of AHSCT and MS Therapies

报名条件(概要)

  • 年龄:18 Years – 不限
  • 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

United Kingdom

药品与企业信息

Autologous haematopoietic stem cell transplantation (AHSCT)治疗操作

Exposure to autologous haematopoietic stem cell transplantation received as part of routine clinical care for multiple sclerosis. AHSCT uses the participant's own blood-forming stem cells following immune-suppressing treatment. Treatment is not assigned or administered by the study.

High-efficacy disease-modifying therapy (HE-DMT)药物

Exposure to an eligible high-efficacy disease-modifying therapy received as part of routine clinical care for multiple sclerosis. Therapies may include alemtuzumab, cladribine, natalizumab, anti-CD20 monoclonal antibody therapies, and other eligible high-efficacy disease-modifying therapies available during the study. Treatment is not assigned or administered by the study.

研发企业

Imperial College London研究机构/其他

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

  • Imperial College Healthcare NHS Trust研究机构/其他
  • University College London Hospitals研究机构/其他
  • King's College Hospital NHS Trust研究机构/其他

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)

Multiple sclerosis (MS) is a condition in which the immune system damages the brain and spinal cord. Treatments called disease-modifying therapies can reduce inflammation and disease activity. For some people with highly active MS, autologous haematopoietic stem cell transplantation (AHSCT) may be used. AHSCT uses a person's own blood-forming stem cells after treatment that suppresses the immune system. REAL-MS is an observational study that will collect and analyse information from routine clinical care to compare the longer-term effectiveness and safety of AHSCT with high-efficacy disease-modifying therapies for adults with MS. High-efficacy therapies include medicines such as alemtuzumab, cladribine, natalizumab, and anti-CD20 antibody treatments, as well as other high-efficacy disease-modifying therapies that may become available during the study.

适应症

Multiple SclerosisMultiple Sclerosis (MS) - Relapsing-remittingMultiple Sclerosis (MS) Primary Progressive

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 →

研究中心联系方式

问自己是否符合条件、如何预筛

我的病情档案

管理档案

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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: REAL-MS: Observational Database Study of AHSCT and MS Therapies
ClinicalTrials.gov Identifier: NCT07899502
Sponsor: Imperial College London
Investigational product: Autologous haematopoietic stem cell transplantation (AHSCT), High-efficacy disease-modifying therapy (HE-DMT)

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:REAL-MS: Observational Database Study of AHSCT and MS Therapies
试验编号:NCT07899502
申办方:Imperial College London
研究药物:Autologous haematopoietic stem cell transplantation (AHSCT)、High-efficacy disease-modifying therapy (HE-DMT)

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)
用邮件客户端发送给 richard.nicholas3@nhs.net

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?

  1. 把本页信息带给您的主治医生,评估是否适合参加。
  2. 点击下方按钮打开官方注册页,查看研究中心联系方式。
  3. 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)。
在 ClinicalTrials.gov 查看官方页面