Predictive Role of Microbiome in Patients With Urothelial Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 420
- 主要终点
- Establish the change of microbial profile in high-grade NMIBC patients after BCG administration
研究概览
简要总结
This study aims to establish the microbiota composition as a predictive tool for the response to the intravesical immunotherapy with Bacillus Calmette-Guérin (BCG) and 2 different chemotherapies schemes.
In this prospective cohort study patients with low/intermediate/high risk non muscle invasive bladder carcinoma (NMIBC) that undergo BCG/chemo treatment will be enrolled to collect urine stool and blood at different endpoints. Microbiota, short-chain fatty acids and immunophenotype will be quantified to develop a predictive screening platform, which might also integrate traditional urinary cytology and FISH data.
详细描述
The purpose of this research is to understand the possible use of microbial profile from catheterized urine and feces of patients with NMIBC to categorize patients in two groups: those likely to respond positively and those unlikely to respond to the therapy. Goal of this study is to identify the predictive role of the microbiome to therapy response, thus allowing clinicians to deliver the most appropriate treatment based on the microbiome (microbiome-personalized therapy).
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥ 18 years, all able to signed informed consent form;
- •Diagnosis of NMIBC provided by an experience pathology, by using tissue specimens that were staged according to the TNM classification and morphoarchitectural criteria according to the WHO classification.
排除标准
- •Participants with ongoing urinary tract infection;
- •Antibiotic treatment within the last month;
- •Immuno-/chemo- therapy within the past 3 months;
- •Chronic immunosuppressive therapy;
- •Additional major diagnosis known to affect the gut or bladder microbiota;
- •Use of probiotics;
- •Uncontrolled diabetes;
- •Participants with other malignancy or previous history of oncological or autoimmune diseases.
结局指标
主要结局
Establish the change of microbial profile in high-grade NMIBC patients after BCG administration
时间窗: 2 years
Establish the change of urinary and fecal microbiome richness and diversity, and immunophenotype in bladder carcinoma patients after intravesical BCG treatment.
次要结局
- The predictive role of microbiome in BCG responsiveness(11 years)