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临床试验/NCT05799456
NCT05799456已完成不适用

Glycosaminoglycan Scores as Early Detection Biomarkers in Bladder Urothelial Carcinoma

Jens Nielsen1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
106
试验地点
1
主要终点
Area-under-the-receiving operating characteristic (ROC)-curve (AUC) for the classification of BCa versus NED

研究概览

简要总结

Early detection of bladder cancer (BCa) is considered an effective strategy to curb mortality from the disease. However, current urinary biomarkers have insufficient specificity to warrant BCa screening. Urine free glycosaminoglycan profiles (or GAGomes) are promising noninvasive biomarkers of cancer metabolism. In this study, samples are obtained from patients with BCa and controls to compare the glycosaminoglycan profiles between groups.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Primary BCa diagnosis at cystoscopy, planned for TURB

排除标准

  • •No histopathological diagnosis of BCaTa-T4 N0-2 MX-0 after TURB
  • •Controls (No evidence of disease [NED])
  • •Inclusion Criteria:
  • •In follow-up with cystoscopy after treatment Ta-T3 N0-2 M0 BCa or upper tract urothelial cancer no evidence of disease at cystoscopy for at least 6 months prior to inclusion
  • •No history of cancer except urothelial
  • •Exclusion Criteria:
  • •Positive cytology at inclusion visit
  • •Intravesical instillation therapy during 6 months prior to inclusion visit

结局指标

主要结局

Area-under-the-receiving operating characteristic (ROC)-curve (AUC) for the classification of BCa versus NED

时间窗: Before primary surgery for BCa; at a post-surgical follow-up visit for controls up to 5 years from primary surgery

次要结局

未报告次要终点

研究者

发起方
Jens Nielsen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jens Nielsen

Professor

Chalmers University of Technology

研究点 (1)

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