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临床试验/NCT04415697
NCT04415697已完成不适用

Identification of Predictive Gene Expression Profile of Sunitinib Rate Response in Metastatic Clear Cell Renal Carcinomas

Barretos Cancer Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Identify differentially expressed genes in two groups of objective response rate.

研究概览

简要总结

Renal cell carcinoma accounts for 2-3% of all cancers in western countries. Brazilian kidney cancer data show an incidence of 6,270 new cases for 2018. New target-molecular therapies have emerged in recent years for the treatment of metastatic kidney cancer. Due to the heterogeneity of these patients and the lack of specific markers, therapeutic is currently based on clinical and laboratory analysis. The research for predictive biomarkers may better characterize the kidney cancer therapeutic management. The objectives are to identify a predictive gene expression profile in patients with advanced clear cell renal carcinoma treated with first-line sunitinib and correlate it with rate response, seeking to identify a predictive gene expression profile. As secondary objectives, the investigators will compare the gene expression profile found, with global survival and clinical-pathological characteristics. Materials and methods: To determine through systematic data collection the epidemiological profile, clinical-pathological characteristics, response rate, disease free survival and overall survival of 60 patients with metastatic clear cell renal carcinoma who used sunitinib in the first line between 2009 and 2018 at the Barretos Cancer Hospital. For evaluation of gene expression profile, the investigators will use a panel of a panel with 770 genes related to disease progression using nanostring technology.

Keywords: Renal Cell Carcinoma; Sunitinib; Biomarkers; Gene expression; Nanostring.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Adult patients
  • At least 18 years
  • Metastatic clear cell renal carcinoma
  • Primary tumors sample of nephrectomy or core biopsy

排除标准

  • insufficient sample for molecular analysis
  • Patients with no record of treatment response data
  • Patients with a history of previous systemic treatment for Metastatic clear cell renal carcinoma
  • Patients with second primary synchronic or metachronic tumor undergoing treatment
  • Patients having received less than one cycle of sunitinib in the first line
  • Patients have received previous adjuvant and/or neoadjuvant treatment with an interval < 1 year between the end of treatment and the diagnosis of metastasis.

结局指标

主要结局

Identify differentially expressed genes in two groups of objective response rate.

时间窗: One year

Identify differentially expressed genes, through the nanoString platform, in two groups of objective response rate defined using the RECIST 1.1 criteria.

次要结局

  • Epidemiological characterization of the metastatic clear cell renal carcinoma population treated with sunitinib in the first line, from Barretos Cancer Hospital.(One Year)

研究者

发起方
Barretos Cancer Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andre Octavio Nicolau Sanches

Medical Doctor

Barretos Cancer Hospital

研究点 (1)

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