High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Treatment Patterns: Type of Therapeutic Approach
研究概览
简要总结
The purpose of this study is to understand how the participants with high-risk non-muscle invasive bladder cancer are diagnosed, treated, and cared for in regular clinical practice in Portugal. HR-NMIBC is an early-stage bladder cancer that is limited to the inner lining of bladder but has a considerable high chance of cancer coming back or worsening.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bladder cancer diagnosis between January 1, 2016 and December 31, 2020
- •Tumor stage N0/x and M0/x plus any of the following: Tis (primary CIS); TaG3/HG (high-grade non-invasive papillary carcinoma); or T1 (tumor invading subepithelial connective tissue)
- •Minimal follow-up time of 5 years unless there is premature death event
排除标准
- •Tumor stage at diagnosis classified as TaG1-2, T2-T4, N1-3, or M1
- •History of radical cystectomy performed either prior to the HR-NMIBC index diagnosis or for an indication unrelated to the index HR-NMIBC
- •Participation in any interventional clinical trial during the observation period
研究组 & 干预措施
HR-NMIBC Participants: Portuguese Routine Practice
Participants diagnosed with high-risk non-muscle-Invasive bladder cancer (HR-NMIBC) in Portugal between January 1, 2016 and December 31, 2020, with tumor stage N0/x and M0/x and one of the following: Tis (primary CIS), TaG3/HG, or T1 will be enrolled. Demographic and clinical information will be gathered from both electronic and paper records for each participant. Only data available within routine clinical practice from the diagnosis until, at least, 5 years after diagnosis will be collected in this study. No drug will be administered as a part of this study.
结局指标
主要结局
Treatment Patterns: Type of Therapeutic Approach
时间窗: Up to 5 years
Number of participants receiving different types of therapeutic approach including bacillus calmette-guerin (BCG) therapy, chemotherapy, radiotherapy, immunotherapy, or targeted therapy will be reported.
Treatment Patterns: Type of Surgery
时间窗: Up to 5 years
Number of participants undergoing different types of surgery, including transurethral resection of the bladder tumor (TURBT), repeat TURBT or cystectomy will be reported.
Treatment Patterns by Subpopulation: Tumor Stage
时间窗: Up to 5 years
Number of participants by tumor stage will be reported.
Treatment Patterns by Subpopulation: Histology
时间窗: Up to 5 years
Number of participants by histology will be reported.
Treatment Patterns by Subpopulation: Line of Therapy
时间窗: Up to 5 years
Number of participants by line of therapy will be reported,
次要结局
- Total Number of BCG Doses Administered(Up to 5 years)
- Percentage of Participants With BCG Non-Responsive Disease(Up to 5 years)
- Reasons for BCG Interruption(Up to 5 years)
- Therapy Choice at Recurrence(Up to 5 years)
- Recurrence-Free Survival (RFS)(Up to 5 years)
- Progression-Free Survival (PFS)(Up to 5 years)
- Overall Survival (OS)(Up to 5 years)
- Metastasis-Free Survival (MFS)(Up to 5 years)
- Time to Next Treatment (TTNT)(Up to 5 years)
- Time on Treatment (TOT)(Up to 5 years)
- Complete Response Rate (CR)(Up to 5 years)
- Number and Type of Healthcare Resource Utilization Related to HR-NMIBC(Up to 5 years)