Profiling Urinary Microbiota In Male Patients With Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- To characterize the microbiota in health and bladder cancer, and may lead to new prevention, diagnosis and treatment strategies for 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
-Rationaly and objectives:
A- Bladder Cancer:
Rationale Bladder cancer is estimated to be the ninth most frequent malignant disease, with 160,000 or more deaths per year estimated globally.
There is an increasingly awareness of the important role of microbes that are inhabiting in the urinary tract that are playing an important role in maintenance of health and the development of diseases and bladder cancer [1].
There is a well-established correlation between initiation of bladder cancer and specific microbial agents [2,3,4,5,].
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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.
- •Exclusion criteria:
- •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.
排除标准
- 未提供
结局指标
主要结局
To characterize the microbiota in health and bladder cancer, and may lead to new prevention, diagnosis and treatment strategies for bladder cancer
时间窗: Sample sollection 12 months, next generation sequencing ind bioinformatics 6 months, interpretation of data 6 months.
Biochemestry and molecular biology assessment: 16S Metagenomic Sequencing analysis Whole genomic sequencing (WGS) will be applied to all cases, methodology and quality control are according to the genomic and metagenomic center in the children cancer hospital 57357 who are going to perform the WGS and 16S sequencing on urine and tissue samples. 1- DNA isolation from urine and tissue. Urine specimens (50ml) will be thawed and centrifuged at 7500g, 4°C for 10minutes. The pellet will be used for DNA extraction using Invitrogen™ PureLink™ Microbiome DNA Purification Kit, performed according to manufacturer's protocol. To avoid environmental contamination, all isolations from urine samples and from the reagent-only extraction control will be carried out within a PCR hood. Isolated DNA samples will be placed at -20 °C until PCR amplifcation. DNA will be quantifed using DeNovix dsDNA High Sensitivity Assay Kit (Illumina 2013) . 2- PCR based KABA KAPA Library Quantification Kits contain all
次要结局
未报告次要终点
研究者
Mohamed Wishahi
Professor Doctor
Theodor Bilharz Research Institute