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临床试验/NCT04970472
NCT04970472招募中不适用

Bio Clinical Collection of Urothelial Carcinoma

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2021年11月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
Collection and long-term collection of blood, urines, stool and tumor samples from patients with Urothelial bladder carcinoma for future biological and/or surrogate marker studies.

研究概览

简要总结

The goal of this study is to collect tumor samples, urines, stool and blood from patients with urothelial carcinoma. These samples will be stored in a secure and confidential laboratory of the Toulouse University Hospital.

详细描述

Recent studies have shown that the bladder also harbors friendly bacteria that are collectively called the microbiome. While the effect of the bladder microbiome to health remains to be more clearly understood, an imbalance in the microbiome is associated with several urinary diseases including overactive bladder and bladder cancer. But whether the microbiome affects the outcome of Bacille Calmette et Guérin (BCG)-immunotherapy or chemotherapy in bladder cancer is still not known.

Researchers at Toulouse University Hospital want to learn as much as possible about bladder cancer. One way to do so is by studying what is in your urines, blood, stool, saliva and in your tumor.

Patients, who will be agree to take part in this study, will have at least about one tablespoon of blood (as a residual of current biological analysis), 1 container of urines, stool and saliva collected before bladder resection.

After transurethral bladder resection or radical cystectomy scheduled as part of the standard of care, some tumor samples might be collected either as fresh tissue or as paraffin embedded tissue and store in a secure and confidential laboratory at Toulouse University Hospital.

The patient's follow up will be schedule as the standard of care and no additional visit will be required for the study. Oncological outcome of each patient will be recorded up to 5 years This is an investigational study in which up to 500 patients will take part in the collection. All patients will be all enrolled at Toulouse University Hospital.

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

入选标准

  • Adult >18 years old
  • Patient with suspected or diagnosed Urothelial carcinoma
  • Patients who are willing to consent for this protocol.

排除标准

  • Pregnant or breastfeeding patients
  • Patients under 18 years old
  • Patients under guardianship or curators
  • Patients unable to sign a free and informed consent

研究组 & 干预措施

patients with Urothelial bladder carcinoma

collection of blood, urines, stool and tumor samples

干预措施: collection of blood, urines, stool and tumor samples (Biological)

结局指标

主要结局

Collection and long-term collection of blood, urines, stool and tumor samples from patients with Urothelial bladder carcinoma for future biological and/or surrogate marker studies.

时间窗: during the intervention/procedure/surgery

Transcriptomic, proteomic and epigenetic analysis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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