跳至主要内容
临床试验/NCT04770974
NCT04770974Unknown不适用

Definition of Tumor Bio-markers and Physical-spectroscopic Differences Between Healthy Urothelial Tissue Healthy and Urothelial Cancer

University of Florence1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年12月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Metabolomic

研究概览

简要总结

Our multicenter observational study is a non-profit prospective study. The study was born from the Amplitude Project, which comprise the SOD of Minimally Invasive Robotic Urological Surgery and Renal Transplants of AOU Careggi with the University of Florence, as well as with the National Research Council (CNR) and the University of Milan Bicocca (UNIMIB) The study consists of a phase of enrollment of patients who will be admitted to the SOD of Mini Invasive Robotic Urological Surgery and Renal Transplantation of AOU Careggi. Enrollment in the study does not alter normal clinical practice and does not involve additional risks for patients. Patients will have to meet the inclusion and exclusion criteria of the study and will be enrolled sequentially, until the established sample size is reached. Patients undergoing surgery for the removal of bladder neoplasm, be it endoscopic or surgical with radical intent (cystectomy), will be taken a fragment of tumor bladder tissue, on which histopathological analysis will be performed. In patients undergoing radical cystectomy only, a fragment of healthy urothelial tissue, free from neoplasia, will also be removed. The samples will be performed in patients under general and / or spinal anesthesia in case of TURB, thus not causing pain or discomfort to the patient, or ex-vivo on the operative piece in case of radical cystectomy, without causing further damage or pain to the patient. From these samples, specially stored in solutions that keep their characteristics unaltered, a 3D culture model (organoid) will be obtained both from cells obtained from bladder cancer and from healthy tissue on which biomolecular, metabolomic and spectroscopic characterization studies will be tested and carried out. with a view to staging and grading bladder neoplasia.

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
All
接受健康志愿者

入选标准

  • Age>18 years
  • Bladder Cancer diagnosis
  • Capability to express informed consent

排除标准

  • Age under 18
  • Pregnancy
  • Lack of informed consent
  • Inability to provide informed consent

结局指标

主要结局

Metabolomic

时间窗: Enrollment

Metabolomic characteristic of bladder cancer

Spectroscopy

时间窗: Enrollment

Spectroscopical characteristic of bladder cancer

次要结局

  • Transcriptomic(Enrollment)
  • Response to treatments(Seven years)
  • Survival(Seven years)
  • Progression(Seven years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Simone Morselli

PhD Student

University of Florence

研究点 (1)

Loading locations...

相似试验