Glycosaminoglycan Scores as Early Detection Biomarkers in Bladder Urothelial Carcinoma
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
Jens Nielsen
Professor
Chalmers University of Technology
