Gag-layer in the Urothelium of the Human Upper Urinary Tract
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Identification of a GAG layer in the upper urinary tract
研究概览
简要总结
Urothelial carcinomas of the lower and upper urinary tract can be considered "twin diseases". Much of the current clinical decision-making surrounding Upper Tract Urothelial Carcinoma (UTUC) is extrapolated from evidence that is based on urothelial carcinoma of bladder patients.
The inner wall of the bladder is coated with a substance called glycosaminoglycan (GAG). GAG is known to form a gel-like layer on the apical cell membrane and act as a barrier against urine and pathogens in the lower urinary tract.
Currently no published research on the presence of a GAG layer in the upper urinary tract exists. However, literature suggests that the ureteral utothelium can be transduced without enhancers, and the ureteral urothelium may be intrinsically different from bladder, both by the presence or absence of a GAG-layer, by different composition/thickness of the GAG-layer.
Any functional differences between the urothelial layers in the bladder and in the upper urinary tract may affect the adeno-virus transduction, which again will have potential impact on future treatment of UTUC patients with a current unmet medical need.
详细描述
This study will include patients either undergoing radical nephrectomy or radical cystectomy. After organ removal during surgery a biopsi (1x1 cm) will be collected from the ureter and the renal pelvis or from the ureter and the bladder (depending on type of surgery).
These biopsies will be examined and compared, using molecular biotechniques, for the presence of glykosamino glykan (GAG) layer.
There is no project related follow up for patients included, other than what is standard post-operative regime in the department.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Bladder cancer or renal cell carcinoma
- •Ability to understand and sign informed consent form
排除标准
- •Previous history of cancer
- •Immune suppressing medication
- •Treatment with local or systemic steroids (< 3 months prior to enrollment)
- •Treatment with antibiotics due to urinary tract infection or pyelonephritis (< 3 months prior to enrollment)
- •Previous radiation therapy of the pelvic floor
- •Ureteric stent
- •Dilatation of the upper urinary tract detected on imaging
- •Dilatation of the upper urinary tract detected on imaging
结局指标
主要结局
Identification of a GAG layer in the upper urinary tract
时间窗: samples are collected and stained immediately after the surgery, all samples will be compared and analyzed once all samples have been collected
Number of specimens with presence of GAG layer by histopatological staining
次要结局
- Thickness of the potential GAG layer in the upper urinary tract(samples are collected and stained immediately after the surgery, all samples will be compared and analyzed once all samples have been collected)
研究者
Jørgen Bjerggaard Jensen
Professor. MD
Aarhus University Hospital