Biomarkers of Recurrence and Progression in Non-muscle Invasive Bladder Cancer - an Association With Inflammatory Response and Plasminogen Activation System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Tumour recurrence or progression
研究概览
简要总结
Bladder cancer (BC) is one of the most common type of cancer globally. Due to its high incidence rate, high risk of recurrence and progression, and frequent cystoscopy surveillance, BC contributes to major healthcare costs across the world. The goal of this prospective study was to evaluate the prognostic value of novel non-muscle invasive bladder cancer (NMIBC) biomarkers for predicting disease recurrence or progression after radical transurethral resection of bladder tumour (TURBT). The data obtained from this study may help physicians identify patients who are at greater risk of NMIBC recurrence or progression and require close supervision.
详细描述
The aim of our prospective study was to determine the prognostic impact of the inflammatory response and indicators of nutritional status on recurrence and progression of non-muscle invasive bladder cancer (NMIBC) in patients undergoing transurethral resection of bladder tumour (TURBT). We evaluated six biomarkers, 3 in blood serum: soluble urokinase plasminogen activator receptor (sUPAR), plasminogen activator inhibitor-1 (PAI-1), interleukin 8 (IL-8) and 3 in urine: apolipoprotein E (APOE), vascular endothelial growth factor (VEGF), interleukin 8 (IL-8). Furthermore, following indicators of nutritional status were investigated: Glasgow Prognostic Score (GPS) and Modified Glasgow Prognostic Score (mGPS).
The primary endpoint of this study was the recurrence or progression of NMIBC based on the histopathological or cystoscopic result. The study outcome was evaluated during the first surveillance cystoscopy, which was performed in time intervals indicated by European Association of Urology. Based on literature data and statistical assumptions we aimed to recruit 240 patients with NMIBC.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Signed informed consent form
- •Presence or suspicion of tumour in urinary bladder
- •Qualification for the first transurethral resection of bladder tumour
排除标准
- •age < 18 years
- •active urinary tract infection
- •active autoimmune disease
- •end-stage renal failure and renal replacement therapy
- •active hepatitis A, B or C
- •active HIV infection
- •factors disqualifying the patient from adjuvant treatment (intravesical immunotherapy or intravesical chemotherapy)
- •bladder tumour stage T2 or more, or urothelial tumour in a location other than the urinary bladder
- •other cancer or systemic anticancer treatment carried out up to 5 years ago
- •factors disqualifying the patient from surgical treatment, e.g. coagulopathies
- •lack of patient consent to collection of blood and urine samples and to follow-up visits
结局指标
主要结局
Tumour recurrence or progression
时间窗: Up to 1 year
Tumour recurrence or progression based on histopathological result from specimen from follow-up cystoscopy.
次要结局
未报告次要终点