ChiCTR2400081246 版本V1.0 版本创建时间2024/02/27 11:47:12 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2400081246 

最近更新日期：

Date of Last Refreshed on：

2024-02-27 11:46:56 

注册时间：

Date of Registration：

2024-02-27 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于 utLIFE-UC 技术检测尿液微小残留病变(MRD)监控尿路上皮癌复发的多中心前瞻性队列研究

Public title：

A multicenter prospective cohort study on monitoring recurrence of urothelial carcinoma based on detection of urinary microscopic residual disease (MRD) by utLIFE-UC technology

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于 utLIFE-UC 技术检测尿液微小残留病变(MRD)监控尿路上皮癌复发的多中心前瞻性队列研究

Scientific title：

A multicenter prospective cohort study on monitoring recurrence of urothelial carcinoma based on detection of urinary microscopic residual disease (MRD) by utLIFE-UC technology

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

张崔建 

研究负责人：

张崔建 

Applicant：

ZhangCuijian 

Study leader：

ZhangCuijian 

申请注册联系人电话：

Applicant telephone：

+86 18511695818

研究负责人电话：

Study leader's telephone：

+86 18511695818

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

surgeon_zhang@126.com

研究负责人电子邮件：

Study leader's E-mail：

surgeon_zhang@126.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

北京市西城区西什库大街8号

研究负责人通讯地址：

北京市西城区西什库大街8号

Applicant address：

No.8 Xishiku Street, Xicheng District, Beijing

Study leader's address：

Peking University First Hospital,No.8 Xi Shi Ku Da Jie, Beijing, P R China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

北京大学第一医院

Applicant's institution：

Peking University First Hospital

研究负责人所在单位：

北京大学第一医院

Affiliation of the Leader：

Peking University First Hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2023研333

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

北京大学第一医院生物医学研究伦理委员会

Name of the ethic committee：

Peking University First Hospital Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2023-08-10 00:00:00

伦理委员会联系人：

汪科

Contact Name of the ethic committee：

Wang Ke

伦理委员会联系地址：

北京市西城区西什库大街8号

Contact Address of the ethic committee：

Peking University First Hospital,No.8 Xi Shi Ku Da Jie, Beijing, P R China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10 85373066

伦理委员会联系人邮箱：

Contact email of the ethic committee：

wangkebox@126.com

研究实施负责（组长）单位：

北京大学第一医院

Primary sponsor：

Peking University First Hospital

研究实施负责（组长）单位地址：

北京市西城区西什库大街8号

Primary sponsor's address：

Peking University First Hospital,No.8 Xi Shi Ku Da Jie, Beijing, P R China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

北京大学第一医院

具体地址：

北京市西城区西什库大街8号

Institution
hospital：

Peking University First Hospital

Address：

Peking University First Hospital,No.8 Xi Shi Ku Da Jie, Beijing, P R China

经费或物资来源：

高质量临床研究专项

Source(s) of funding：

Specialized high-quality clinical research

Target disease：

1. high-risk upper tract urothelial carcinoma (UTUC) (pT3-4 or N+) 2. non-muscle invasive bladder cancer (NMIBC) (including low-risk, intermediate-risk, and high-risk/very-high-risk) 3. muscle-invasive bladder cancer (MIBC)

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

队列研究 

Study design：

Cohort study 

研究目的：

本研究为一项多中心、前瞻性、非干预、观察性队列研究，入组患者分为4个队列：队列一为高危UTUC（pT3-4或N+）患者；队列二为NMIBC患者（包括低危、中危、高危/极高危）；队列三为拟行新辅助治疗的MIBC患者；队列四为标准TMT治疗后评估为CR的患者（即成功保留膀胱患者）。 主要目的 队列一、四：MRD评分评估影像学复发/转移的敏感性以及特异性； 队列二：MRD评分评估肿瘤复发的敏感性以及特异性； 队列三：MRD评分评估肿瘤残余的敏感性以及特异性。 次要目的 队列一、四：MRD评分评估影像学复发亚组及转移亚组的敏感性以及特异性； 队列二：MRD评分评估复发肿瘤不同分级以及分期的敏感性以及特异性； 队列三：MRD评分评估残余肿瘤不同分级以及分期的敏感性以及特异性。  

Objectives of Study：

This was a multicenter, prospective, non-interventional, observational cohort study, and the enrolled patients were divided into four cohorts: cohort I was patients with high-risk upper tract urothelial carcinoma (UTUC) (pT3-4 or N+); cohort II was patients with non-muscle invasive bladder cancer (NMIBC) (including low-risk, intermediate-risk, and high-risk/very-high-risk); cohort III was patients with muscle-invasive bladder cancer (MIBC) to receive neoadjuvant therapy; and cohort IV was patients evaluated for complete response (CR) after standard trimodality therapy (TMT) treatment (i.e. patients with successful bladder preservation). Primary Objectives Cohorts I and IV: MRD score to assess the sensitivity and specificity of imaging recurrence/metastasis; Cohort II: MRD score to assess the sensitivity and specificity of tumor recurrence; Cohort III: MRD score to assess the sensitivity and specificity of tumor remnants. Secondary Objectives Cohorts I and IV: MRD score to assess the sensitivity and specificity of imaging recurrence subgroup and metastasis subgroup; Cohort II: MRD score to assess the sensitivity and specificity of different grades and stages of recurrent tumors; Cohort III: MRD scores to assess the sensitivity and specificity of different grades and stages of residual tumors.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

队列一：1）在签署知情同意书时年龄≥18岁，有完全民事行为能力患者；2）患者接受术后复查时提供尿液样本用于MRD检测；3）病理类型：要求为经病理证实的原发部位为上尿路（包括肾盂、输尿管）的尿路上皮肿瘤为主的病理类型，允许含有不超过50%的鳞状分化、腺样分化或肉瘤样分化，且为pT3/4或任何TpN+的患者。
队列二：1）在签署知情同意书时年龄≥18岁，有完全民事行为能力患者；2）患者接受术后复查时提供尿液样本用于中心检测；3）病理类型：要求为经病理证实的原发部位为膀胱的尿路上皮肿瘤为主的病理类型，允许含有不超过50%的鳞状分化、腺样分化；允许存在或仅为原位癌；病理分期可为T1、Ta或Tis（Cis）。
队列三：1）在签署知情同意书时年龄≥18岁，有完全民事行为能力患者；2）患者接受新辅助治疗期间每周期治疗前提供尿液样本用于中心检测；3）病理类型：要求TUR手术病理原发部位为膀胱的尿路上皮肿瘤为主的病理类型，允许含有不超过50%的鳞状分化、腺样分化或肉瘤样分化；病理分期为T2或尽管病理分期为T1但综合影像学评估为MIBC的患者；4）新辅助治疗后须行根治性膀胱全切手术治疗，男性切除范围须包括膀胱、前列腺、精囊；女性切除范围须包括膀胱、子宫；淋巴结清扫范围至少为膀胱癌标准清扫范围（包括双侧髂总动脉分叉以下、同侧生殖股神经至输尿管之间的的髂外、髂内及闭孔区域淋巴结）；5）新辅助治疗前需存在基于RECIST1.1标准的影像学可评估病灶。
队列四：1）在签署知情同意书时年龄≥18岁，有完全民事行为能力患者；2）患者接受每次复查时提供尿液样本用于中心检测；3）病理类型：要求TUR手术病理为原发部位为膀胱的尿路上皮肿瘤为主的病理类型，允许含有不超过50%的鳞状分化、腺样分化或肉瘤样分化；4）应有中心影像评估TMT治疗前临床评估为MIBC；5）接受TMT治疗后评估为临床CR，可继续保留膀胱患者，不需接受挽救性膀胱全切手术。

Inclusion criteria

Cohort I: 1) patients ≥18 years of age with full civil capacity at the time of signing the informed consent form;
2) patients who provide a urine sample for MRD testing at the time of undergoing postoperative review;
3) Pathologic type: required to be a pathologically confirmed uroepithelial tumor with a predominantly urothelial tumor with a primary site in the upper urinary tract (including the renal pelvis and ureters), and permitted to contain no more than 50% squamous differentiation, adenomatous differentiation, or sarcomatoid differentiation and are pT3/4 or any TpN+.;
Cohort II: 1) patients aged ≥18 years at the time of signing the informed consent form with full civil capacity;
2) patients who provided a urine sample for central testing when they underwent postoperative review;
3) Pathological type: a pathologically confirmed predominantly uroepithelial tumor with a primary site in the bladder is required, and is permitted to contain no more than 50% squamous differentiation, or adenoidal differentiation;
carcinoma in situ is permitted to be present or only in situ;
and the pathologic stage may be T1, Ta, or Tis (Cis);
Cohort III: 1) patients aged ≥18 years at the time of signing the informed consent form with full civil capacity;
2) patients providing urine samples for centralized testing prior to each cycle of treatment during neoadjuvant therapy;
3) pathology type: a predominantly uroepithelial tumor with a TUR surgical pathology primary site in the bladder is required, and is permitted to contain no more than 50% squamous, adenomatous, or sarcomatoid differentiation (iii) Patients with pathologic stage T2 or MIBC on comprehensive imaging despite pathologic stage T1;
4) Radical cystectomy after neoadjuvant therapy, including bladder, prostate, and seminal vesicles in men and bladder and uterus in women;
5) lymph node dissection at least to the extent of the standard dissection for bladder cancer (including the area of the common iliac arteries below the bifurcation of the iliac arteries bilaterally and the area between the ipsoas and genitofemoral nerve to the ureter);
6) the presence of evaluable lesions on imaging based on RECIST 1.1 criteria prior to neoadjuvant therapy.;
Cohort IV: 1) patients aged ≥18 years at the time of signing the informed consent form with full civil capacity;
2) patients to provide a urine sample for centralized testing at each review visit;
3) pathology type: the TUR surgical pathology is required to be a predominantly uroepithelial tumor with a primary site in the bladder, and is allowed to contain no more than 50% squamous, adenomatous, or sarcomatous differentiation;
4) there should be a centralized imaging to assess a clinical assessment of MIBC prior to TMT treatment;
5) patients assessed as clinically CR after undergoing TMT who can continue to retain their bladder and do not require salvage cystotomy.

排除标准：

队列一：1）根治术后病理不满足入组标准的；2）可预知的无法满足术后1年内在本中心规律复查的；3）不同意规律接受膀胱镜检查和/或影像学检查（至少完成CT或MR或PET/CT的其中一项，复查间隔以及具体项目由临床医生决定）；4）已经明确存在复发或转移的；5）同时合并其他活跃的恶性肿瘤疾病或5年内有其他恶性肿瘤疾病史（不包括积极治疗后的基底细胞癌和宫颈原位癌）；
队列二：1）TUR病理不满足入组标准的；2）可预知的无法满足术后1年内在本中心规律复查的；3）不同意规律接受膀胱镜检查和/或影像学检查（由临床医生决定影像学检查内容及类型）；4）已经明确存在复发或转移的；5）同时合并其他活跃的恶性肿瘤疾病或5年内有其他恶性肿瘤疾病史（不包括积极治疗后的基底细胞癌和宫颈原位癌）；
队列三：1）TUR病理不满足入组标准的；2）不接受根治性膀胱全切手术或标准手术范围的；3）接受不足2周期新辅助治疗的；4）不接受在术前新辅助治疗期间规律接受影像学评估的；5）新辅助治疗之前无可评估病灶的；6）已经明确存在远处转移的； 7) 同时合并其他活跃的恶性肿瘤疾病或5年内有其他恶性肿瘤疾病史（不包括积极治疗后的基底细胞癌和宫颈原位癌）。
队列四：1）TUR病理不满足入组标准的；2）可预知的无法满足术后1年内在本中心规律复查的；3）无治疗前本中心影像的；4）不同意规律接受影像学检查的（由临床医生决定影像学检查内容及类型）；5）已经明确存在残余病灶或转移的；6）同时合并其他活跃的恶性肿瘤疾病或5年内有其他恶性肿瘤疾病史（不包括积极治疗后的基底细胞癌和宫颈原位癌）。

Exclusion criteria：

Cohort I: 1) Pathology after radical surgery that does not meet the criteria for enrollment;
2) Predictable inability to meet the criteria for regular review at our center within 1 year postoperatively;
3) Disagreement with regular cystoscopy and/or imaging (at least completion of one of CT or MR or PET/CT, with intervals between reviews as well as the specific items to be determined by the clinician);
4) Already definite recurrence or metastasis;
5) Concomitant combination of other active malignant neoplastic disease or a history of other malignant neoplastic disease within 5 years (excluding basal cell carcinoma and cervical carcinoma in situ after active treatment);
Cohort II: 1) TUR pathology that does not meet the enrollment criteria;
2) predictable inability to meet the regular review at our center within 1 year postoperatively;
3) disagreement with regular cystoscopy and/or imaging (the content and type of imaging will be determined by the clinician);
4) definite recurrence or metastasis already exists;
5) concurrent combination of other active malignant neoplastic disease or a 5-year history of other malignant neoplastic disease history (excluding basal cell carcinoma and cervical carcinoma in situ after active treatment);
Cohort III: 1) TUR pathology that does not meet enrollment criteria;
2) does not undergo radical total cystectomy or standard surgical scope;
3) receives less than 2 cycles of neoadjuvant therapy;
4) does not undergo regular imaging evaluations during preoperative neoadjuvant therapy;
5) has no evaluable lesions prior to neoadjuvant therapy;
6) already has definitively present distant metastases;
7) concurrently combines other active malignant neoplastic disease or a history of other malignant neoplastic disease within 5 years (excluding basal cell carcinoma and cervical carcinoma in situ after active treatment).;
Cohort IV: 1) TUR pathology that does not meet the inclusion criteria;
2) predictable inability to meet the regular review at our center within 1 year after surgery;
3) no pre-treatment imaging at our center;
4) disagreement with regularity of receiving imaging (the clinician decides on the content and type of imaging);
5) residual lesions or metastases that are already clearly present;
6) concurrent combination of other active malignant neoplastic diseases or a history of other malignant neoplastic diseases within 5 year history of other malignant neoplastic disease (excluding basal cell carcinoma and cervical carcinoma in situ after active treatment).

研究实施时间：

Study execute time：

从 From 2024-03-01 00:00:00至 To 2026-05-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-03-01 00:00:00 至 To 2025-05-31 00:00:00  

干预措施：

Interventions：

组别：

队列一

样本量：

100

Group：

Cohort I

Sample size：

干预措施：

utLIFE-UC

干预措施代码：

Intervention：

utLIFE-UC

Intervention code：

组别：

队列二

样本量：

200

Group：

Cohort II

Sample size：

干预措施：

utLIFE-UC

干预措施代码：

Intervention：

utLIFE-UC

Intervention code：

组别：

队列三

样本量：

50

Group：

Cohort III

Sample size：

干预措施：

utLIFE-UC

干预措施代码：

Intervention：

utLIFE-UC

Intervention code：

组别：

队列四

样本量：

50

Group：

Cohort IV

Sample size：

干预措施：

utLIFE-UC

干预措施代码：

Intervention：

utLIFE-UC

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China 

Province：

Beijing 

City：

 

单位(医院)：

北京大学第一医院 

单位级别：

三级甲等 

Institution
hospital：

Peking University First Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 天津 

市(区县)：

  

Country：

China 

Province：

Tianjing 

City：

 

单位(医院)：

天津医科大学第二医院 

单位级别：

三级甲等 

Institution
hospital：

The Second Hospital of Tianjin Medical University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 四川 

市(区县)：

  

Country：

China 

Province：

Sichuan 

City：

 

单位(医院)：

四川大学华西医院 

单位级别：

三级甲等 

Institution
hospital：

West China Hospital of Sichuan University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

utLIFE-UC MRD 分数

指标类型：

主要指标

Outcome：

utLIFE-UC MRD score

Type：

Primary indicator

测量时间点：

队列一、二、四为术后接受术后影像学/膀胱镜评估当日至术后1年（每3月一次，共4次）， 队列三为每次进行新辅助治疗前直至接受根治手术时

测量方法：

在相应的采集尿液节点提供晨尿100ml进行utLIFE-UC MRD检测；评估结果以分数（0-100分）记录

Measure time point of outcome：

every 3 months for 4 times (Cohort I, II and IV) and before each neoadjuvant therapy (Cohort III)

Measure method：

Provide 100 ml of morning urine for utLIFE-UC MRD testing at the appropriate collection node; assessment results were recorded as a score (0-100)

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

尿液

组织：

Sample Name：

urine

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 99 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

无

Randomization Procedure (please state who generates the random number sequence and by what method)：

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

无

Blinding：

None

是否共享原始数据：

IPD sharing

Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

无

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

None

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

无

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

None

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2024-02-27 11:46:56