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临床试验/NCT04256122
NCT04256122Unknown不适用

Expression of Markers Related to Mitochondrial Functionality in Carcinoma of the Urinary Bladder: Comparative Retrospective Analysis Between Recurrent Tumors ("Non-responders") and Non-recurrent Tumors ("Responders") After Intravesical Treatment With Chemotherapy or Immunotherapy

Istituto Clinico Humanitas1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年10月22日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Immunohistochemestry analysis of biomarkers

研究概览

简要总结

Retrospective monocentric study evaluating different immunohistochemical phenotypes related to mitochondrial functions with treatment outcomes

详细描述

About 80% of newly diagnosed patients have non-muscle-invasive bladder cancer (NMIBC), including papillary lesions confined to the urothelium (stage Ta) or invading the lamina propria (stage T1), and carcinoma in situ (CIS). These tumors show low progression rates, but high recurrence. In particular, patients with multifocal high-grade urothelial carcinoma have a high risk of both recurrence (∼70% after 1 yr) and progression (5% after 1 yr). Initial NMIBC management is a transurethral resection of bladder tumor (TURBT), followed by adjuvant intravesical treatment with the chemotherapeutic agent Mitomycin C (MMC) or the immunotherapy Bacillus Calmette-Guérin (BCG). However, these therapies lead to variable clinical responses and patients recur shortly after surgery. Despite both therapies have been used for decades in the treatment of NMIBC, at the moment it is not possible to predict after initial staging which patients will benefit from them since neither resistance mechanisms nor genetic markers associated to relapse have been identified yet.

In a preliminary analysis, the invesitigators found that low expression of several proteins involved in mitochondrial functions correlate with a worst prognosis in bladder cancer patients. The aim of this study is to detect markers of mitochondrial dysfunction by immunohistochemistry in recurrent tumors ("non-responders") and non-recurrent tumors ("responders") after intravesical treatment with chemotherapy or immunotherapy, and determine the prognostic relevance of these different markers.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •>18 years of age at diagnosis
  • •Histologically confirmed NMIBC urothelial carcinoma of the urinary bladder (pTa, pT1, CIS)
  • •Primary NMIBC or not treated secondary NMIBC, after a primary non-invasive malignancy
  • •Patients underwent TURBT for NMIBC at Humanitas between 2000 and 2019
  • •Patients that received intravesical instillations with either MMC or BCG after TURBT at Humanitas between 2000 and 2019
  • •Written informed consent to research purpose
  • •For non-recurrent tumors ("responders"):
  • •Patient treated with adjuvant MMC or BCG that did not experience recurrence for at least 42 months after TURBT
  • •Patients are tumor-free at the moment of the analysis
  • •For recurrent tumors ("non-responders"):
  • •Patient treated with adjuvant MMC or BCG that experienced recurrence in the first 24 months after TURBT.

排除标准

  • •Previous malignancies other that bladder cancer
  • •Patients with a history of treated bladder cancer recurrences

结局指标

主要结局

Immunohistochemestry analysis of biomarkers

时间窗: 1 year

perform an immunophenotypical analysis to assess the expression of key proteins involved in mitochondrial functionality in recurrent tumors ("non-responders") and non-recurrent tumors ("responders") after intravesical treatment with chemotherapy or immunotherapy.

次要结局

  • Correlation of biomarker expression with outcome(1 year)

研究者

发起方
Istituto Clinico Humanitas
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michele Tedeschi

Head of Clinical Research

Istituto Clinico Humanitas

研究点 (1)

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