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Specimen Collection for Validation of UroAmp: A Next Generation Sequencing Platform for Detection and Surveillance of Bladder Cancer (INSITE)

2026年6月24日更新者：Convergent Genomics, Inc.

This is a prospective, multicenter observational study designed to collect urine and tumor biospecimens and associated clinical data from patients undergoing evaluation, treatment, or surveillance for urothelial carcinoma.

研究概览

地位

招聘中

条件

详细说明

All study participants will provide a urine sample at baseline, study enrollment. Each participant will then be followed longitudinally for up to 5 years during which urine, tissue (if applicable), and clinical data will be collected from the standard of care clinical visits. Urine samples will be collected in Convergent Genomics' proprietary urine collection system.

研究类型

观察性的

注册 (估计的)

2500

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

波多黎各
- - San Juan、波多黎各、00907
    - 主动，不招人
    - Ashford Med Center
  - San Juan、波多黎各、00935
    - 主动，不招人
    - PanOncology
美国
- California
  - Oceanside、California、美国、92056
    - 主动，不招人
    - Urology San Diego
  - San Diego、California、美国、92123
    - 主动，不招人
    - Genesis Research, LLC
  - San Jose、California、美国、95124
    - 主动，不招人
    - Urology Associates of Silicon Valley
- Illinois
  - Chicago、Illinois、美国、60657
    - 主动，不招人
    - UroPartners, LLC
  - Grayslake、Illinois、美国、60030
    - 主动，不招人
    - UroPartners, LLC
  - Mount Prospect、Illinois、美国、60056
    - 主动，不招人
    - UroPartners, LLC
  - Niles、Illinois、美国、60068
    - 主动，不招人
    - UroPartners, LLC
  - Wheaton、Illinois、美国、60187
    - 主动，不招人
    - UroPartners, LLC
- Maryland
  - Hanover、Maryland、美国、21076
    - 主动，不招人
    - Chesapeake Urology Research Associates
- Michigan
  - Royal Oak、Michigan、美国、48073
    - 主动，不招人
    - Comprehensive Urology
- Nevada
  - Las Vegas、Nevada、美国、89144
    - 主动，不招人
    - Sheldon J. Freedman MD LTD
- New York
  - New York、New York、美国、10016
    - 主动，不招人
    - Manhattan Medical Research Practice
- Ohio
  - Cincinnati、Ohio、美国、45212
    - 主动，不招人
    - The Urology Group
- Tennessee
  - Nashville、Tennessee、美国、37209
    - 主动，不招人
    - Urology Associates, P.C.
- Texas
  - Austin、Texas、美国、78681
    - 主动，不招人
    - Urology Austin - Round Rock
  - Austin、Texas、美国、78705
    - 主动，不招人
    - Midtown Urology Associates
  - Austin、Texas、美国、78759
    - 主动，不招人
    - Urology Austin - Medical Park Tower
  - Dallas、Texas、美国、75390
    - 招聘中
    - UT Southwestern Medical Center
    - 接触：
      
      Perla Lopez
      
      电话号码：214-645-8787
      
      邮箱：Perla.Lopez@utsouthwestern.edu
  - San Antonio、Texas、美国、78229
    - 主动，不招人
    - Urology San Antonio
  - San Antonio、Texas、美国、78229
    - 主动，不招人
    - UT Health San Antonio
- Virginia
  - Virginia Beach、Virginia、美国、23462
    - 主动，不招人
    - Urology of Virginia

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不

取样方法

概率样本

研究人群

Adult patients undergoing evaluation, treatment, or surveillance for urologic tract cancers, including bladder cancer, upper tract urothelial cell carcinoma, or urethral urothelial cell carcinoma, as well as individuals undergoing evaluation for hematuria. Participants are identified and enrolled at participating clinical sites.

描述

Inclusion Criteria:

GROUP 1: Bladder Cancer and/or Upper Tract UCC

Male or female ≥ 18 years of age who are scheduled for transurethral resection of bladder tumor (TURBT) and/or biopsy of urinary tract or
Patients on surveillance who are negative for recurrence or tumor at the time of study enrollment but have had previous urothelial cell carcinoma (UCC) or
Patients with muscle invasive bladder cancer (MIBC) or non-muscle invasive bladder cancer (NMIBC) scheduled for NAC and/or subsequent radical cystectomy (RC)
Able to provide consent prior to diagnostic TURBT, nephroureterectomy, or administration of NAC and/or RC
Able to provide at least 20cc urine. If patient cannot void sufficient volume of urine, urologist can pull urine from the bladder via catheter or cystoscope. Urine should not be collected immediately after resection
Participation in other bladder cancer studies is allowed. Experimental therapy must be documented in the case report forms

GROUP 2: Hematuria Controls

Male or female ≥ 18 years of age presenting with gross or microscopic hematuria as defined by standard of care
No evidence of and/or history of bladder cancer, upper tract UCC, kidney cancer and/or prostate cancer at the time of collection
Able to provide consent
Able to provide at least 20cc urine
Participation in other studies is allowed. Experimental therapy must be documented in the case report forms

Exclusion Criteria:

GROUP 1: Bladder Cancer and/or Upper Tract UCC

Clinical, symptomatic urinary tract infection at time of initial urine collection
Unable to provide adequate urine sample

GROUP 2: Hematuria Controls

- Evidence and/or History of bladder cancer, upper tract UCC, kidney cancer and/or prostate cancer at the time of collection

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
Bladder Cancer and/or Upper Tract Urothelial Cell Carcinoma (UCC)
Hematuria Controls

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Recurrence Free Survival (RFS) 大体时间：From enrollment through completion of available clinical follow-up, up to 5 years.	RFS is defined as the time from the urine specimen collection to the first histopathologically confirmed recurrence of urothelial carcinoma	From enrollment through completion of available clinical follow-up, up to 5 years.
Diagnostic Detection Performance in Hematuria Triage 大体时间：From enrollment through completion of diagnostic evaluation, up to 5 years.	Sensitivity, specificity, positive predictive value and negative predictive value of the investigational urine assay for the detection of urothelial cancer among subjects undergoing evaluation for hematuria, comparing subjects with histopathologically confirmed cancer to subjects without evidence of cancer at the time of diagnostic workup.	From enrollment through completion of diagnostic evaluation, up to 5 years.

次要结果测量

结果测量	措施说明	大体时间
Comparison to Alternative Urine Biomarkers 大体时间：From enrollment up to 5 years.	Comparison of the investigational urine biomarker to alternative urine biomarker assays, including cytology and UroVysion FISH, for the detection of urothelial cancer recurrence. Comparison will include lead time, sensitivity, specificity, negative predictive value, and positive predictive value.	From enrollment up to 5 years.
Lead Time for Detection of Cancer Recurrence 大体时间：From enrollment up to 5 years.	A subject with diagnostic lead time will be defined as a subject with a negative cystoscopy and concurrent positive investigational urine biomarker with confirmed urothelial cancer recurrence on study. Lead time will be calculated as the time from the positive urine biomarker result to the date of histopathologic confirmation.	From enrollment up to 5 years.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Convergent Genomics, Inc.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年10月15日

初级完成 (估计的)

2034年12月1日

研究完成 (估计的)

2034年12月1日

研究注册日期

首次提交

2026年6月9日

首先提交符合 QC 标准的

2026年6月24日

首次发布 (实际的)

2026年6月29日

研究记录更新

最后更新发布 (实际的)