EpiCheck and Short-term Intensive Chemoresection in NMIBC
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- EpiCheck result
研究概览
简要总结
The aim of this explorative study is to evaluate whether EpiCheck can be used as a predictor of tumour response to short-term, intensive chemoresection with Mitomycin.
详细描述
The study will be conducted as an exploratory, prospective observational study. Participants consists of patients referred to short-term, intensive chemoresection due to recurrent NMIBC. The treatment adhere to the regimen described in the NICSA trial with the ClinicalTrials.gov identifier NCT03348969. Treatment consists of short-term, intensive chemoresection with Mitomycin; 40 mg is administered intravesically three times a week for two weeks. To evaluate tumour response, an early cystoscopy is performed in the outpatient clinic one to two months after treatment completion. No visible tumour and residual tumour with benign histology is considered complete response. Residual tumour tissue with neoplastic histology is considered incomplete response and will be treated with TURBT or tumour fulguration. Subsequently patients continue a standardized follow-up program as Danish guidelines prescribe which is initiated after four months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patients with a known history of Ta HG with recurrent disease
- •Patients referred to short-term, intensive chemoresection
- •Patients older than 18 years
排除标准
- •Known allergy or intolerance to Mitomycin
- •Incontinence or small bladder capacity (< 100 mL)
- •Previous pelvic radiation therapy
结局指标
主要结局
EpiCheck result
时间窗: One to two months after short-term, intensive chemoresection
Number of patients with accordance between EpiCheck score and clinical findings at the time of evaluation cystoscopy
次要结局
- EpiCheck result 3(One to two months after short-term, intensive chemoresection)
- EpiCheck result 2(One to two months after short-term, intensive chemoresection)
- Urine cytology(One to two months after short-term, intensive chemoresection)
研究者
Maria Skydt Lindgren
Principal Investigator
Aarhus University Hospital