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正在招募II 期 / III 期编号 NCT05987241

Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study

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 States、Canada

药品与企业信息

Biospecimen Collection治疗操作

其他名称：Biological Sample Collection、Biospecimen Collected、Sample Collection、Specimen Collection

Undergo collection of tissue and blood

cfDNA or ctDNA Measurement其他

其他名称：Cell-Free DNA/Circulating Tumor DNA Measurement、cfDNA/ctdDNA Measurement、cfDNA/ctDNA、cfDNA/ctDNA Measurement、Circulating Cell-Free DNA/Circulating Tumor-Derived DNA Measurement

Undergo ctDNA surveillance

Computed Tomography治疗操作

其他名称：CAT、CAT Scan、Computed Axial Tomography、Computerized Axial Tomography、Computerized axial tomography (procedure)、Computerized Tomography

Undergo CT

Cystoscopy治疗操作

其他名称：CS

Undergo cystoscopy

Magnetic Resonance Imaging治疗操作

其他名称：Magnetic Resonance、Magnetic Resonance Imaging (MRI)、Magnetic resonance imaging (procedure)、Magnetic Resonance Imaging Scan、Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance、MR

Undergo MRI

Nivolumab生物制品

其他名称：ABP 206、BCD-263、BMS 936558、BMS-936558、BMS936558、CMAB819

Given IV

Questionnaire Administration其他

Ancillary studies

Relatlimab生物制品

其他名称：BMS 986016、BMS-986016、BMS986016、Immunoglobulin G4, Anti-(human Lymphocyte Activation Gene-3 Protein) (Human Heavy Chain), Disulfide with Human Light Chain, Dimer

Given IV

研发企业

National Cancer Institute (NCI)美国国立卫生研究院

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）

This phase II/III trial examines whether patients who have undergone surgical removal of bladder, kidney, ureter or urethra, but require an additional treatment called immunotherapy to help prevent their urinary tract (urothelial) cancer from coming back, can be identified by a blood test. Many types of tumors tend to lose cells or release different types of cellular products including their DNA which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for disease progression or relapse. In this study, a blood test is used to measure ctDNA and see if there is still cancer somewhere in the body after surgery and if giving a treatment will help eliminate the cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and relatlimab, can help the body's immune system to attack the cancer, and can interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine if ctDNA measurement in blood can better identify patients that need additional treatment, if treatment with nivolumab prolongs patients' life and whether the additional immunotherapy treatment with relatlimab extends time without disease progression or prolongs life of urothelial cancer patients who have undergone surgical removal of their bladder, kidney, ureter or urethra.

适应症

Muscle Invasive Bladder Urothelial CarcinomaMuscle Invasive Renal Pelvis Urothelial CarcinomaMuscle Invasive Ureter Urothelial CarcinomaMuscle Invasive Urethral Urothelial CarcinomaStage II Bladder Urothelial Carcinoma AJCC v6 and v7Stage III Bladder Urothelial Carcinoma AJCC v6 and v7

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

档案只保存在您自己的浏览器里，不会上传，任何人（包括本站）都看不到。

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: Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
ClinicalTrials.gov Identifier: NCT05987241
Sponsor: National Cancer Institute (NCI)
Investigational product: Biospecimen Collection, cfDNA or ctDNA Measurement, Computed Tomography, Cystoscopy, Magnetic Resonance Imaging

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：Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
试验编号：NCT05987241
申办方：National Cancer Institute (NCI)
研究药物：Biospecimen Collection、cfDNA or ctDNA Measurement、Computed Tomography、Cystoscopy、Magnetic Resonance Imaging

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 ResearchInstituteInquiries@CommonSpirit.org

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