Microscopic-spectroscopic Examination for Urothelial Tissue Characterization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 主要终点
- diagnostic concordance
研究概览
简要总结
To evaluate the possibility to properly discriminate between healthy bladder tissue and BCa with a multimodal fiber optic spectroscopy (MFOS) technique, in order to possibly introduce a more objective way to detect BCa, thus reducing inter-observer variability and maybe to determine urothelial carcinoma stage and grade with a comparable accuracy, specificity and sensibility of the current gold standard histopathological analysis
详细描述
Observational single center study on human biological samples to evaluate the possibility to discriminate between healthy and tumor tissue on urothelial bladder samples. Aim of the study is to provide a fast, reliable and label free aid/alternative to current histopathology
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
- •willingness to participate,
- •legal age,
- •full capacity to sign informed consent
- •eligibility for each surgical operation according to the best clinical practice and the urological guidelines
排除标准
- •concomitant use of Hexaminolevulinate (Hexvix®)
- •concomitant ongoing UTIs,
- •concomitant bladder stone presence,
- •recent catheterization or persistent bladder catheterization at time of surgery,
- •concomitant presence of other pelvic cancer (both prostate, urethral, uterine),
- •previous chemotherapy or radiotherapy of the pelvis,
- •patient refusal at informed consent.
结局指标
主要结局
diagnostic concordance
时间窗: 30 minutes from resection
concordance in identifying healthy and tumor tissue between multimodal fiberoptic spectroscopy and pathology, considered as gold standard
次要结局
- staging concordance(30 minutes from resection)
- grading concordance(30 minutes from resection)
研究者
Gianluca Villa
MD, clinical researcher
Careggi Hospital