Profiling Urinary Microbiota in Male Patients With Bladder Cancer- An Exploratory Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- To characterize the microbiota in male patients with bladder cancer.
研究概览
简要总结
Microbes inhabiting the urinary tract that are playing an important role in maintenance of health and the development of diseases and bladder cancer. There is correlation between initiation of bladder cancer and microbes. Urine and bladder tissues from healthy individuals and patients with bladder cancer were analyzed using 16S rRNA sequencing, results show abundant phylum. Next-generation sequencing technologies will be applied with whole genomic and 16S ribosomal RNA gene sequencing for microbiota profiling in urine and bladder tissue of male healthy individuals and patients with bladder cancer. Results will lead to prevention, diagnosis, and new treatment strategies for bladder cancer.
详细描述
Objectives The aim of this research study is to characterize the urinary microbiota of adult male patients with bladder cancer and to be correlated with microbiota in healthy adult males controls.
2-Methodology 2-1 Study type: Prospective case control study 2-2 Inclusion, exclusion criteria, recruitment process. [ included patients in the study will be asked to offer an informed consent, Dr Loay Mostafa and Dr. Mohamed Sahab from the Urology Department - TBRI will be responsible for this item].
Inclusion Criteria:
- Adult men above 18 years,
- Diagnosed of carcinoma of the bladder with imaging ultrasonography and/ or computerized tomography, and urine cytology.
- Confirmed bladder cancer either during diagnostic cystoscopy, previous pathology, or pathological examination of the biopsy specimens.
Exclusion criteria:
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Adult men above 18 years,
- •Diagnosed of carcinoma of the bladder with imaging ultrasonography and/ or computerized tomography, and urine cytology.
- •Confirmed bladder cancer either during diagnostic cystoscopy, previous pathology, or pathological examination of the biopsy specimens.
排除标准
- •- Previous radiotherapy to the bladder or to adjacent organ.
- •Previous intravesical instillation immunotherapy with bacillus Calmette-Guérin (BCG), or intravesical instillation of chemotherapeutics.
- •Previous neoadjuvant chemotherapy.
结局指标
主要结局
To characterize the microbiota in male patients with bladder cancer.
时间窗: 2 years
Urine and tissue samples from patients will bladder cancer will be examined with next generation sequencing for whole genomic and with 16S rRNA to define the microbiota distribution in cancer patients and in healthy control(Urine sample)-
次要结局
未报告次要终点
研究者
Mohamed Wishahi
Prof Dr
Theodor Bilharz Research Institute