跳至主要内容
临床试验/NCT00942058
NCT00942058终止不适用

Serum Carbonic Anhydrase 9 (CA9) Level as Biological Marker of the Treatment Response in Metastatic Renal Cell Cancer : a Pilot Study

Centre Hospitalier Universitaire de Saint Etienne3 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2009年6月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
16
试验地点
3
主要终点
serum protein CA9 and mRNA CA9 level under medical treatment

研究概览

简要总结

One third of patients with kidney cancer are diagnosed in the metastatic stage, and among patients with a localized form, about 30 to 40% will develop metastases after surgery.

Medical treatment of metastatic renal cancer include immunotherapy with interferon α and/or IL-2, or targeted therapies such as anti-angiogenic (anti-vascular endothelial growth factor (VEGF), anti-tyrosine kinase inhibitors and m-TOR). These treatments sometimes associated (or IL2 + INF or INF AntiVEGF) do allow for objective response in 15 to 30% of cases (net benefit of targeted therapies), but are carriers of potentially significant side effects and are very expensive. The treatment response is considered on imaging exams repetitive, costly and inconsistently reliable. A serum marker of tumor development would be particularly welcome.

CA9 is an oncogene also know as CA IX, carbonic anhydrase 9 or MN/CA9. The gene encoding an oncoprotein called indifferently membrane antigen MN, MN/CA9 isoenzyme, carbonic anhydrase IX CA9, G250/MN/CA9 or protein G250. It was demonstrated that the level of expression of CA9 in tumor tissue can be used as a predictive marker of response to immunotherapy.

In previous studies, the investigators tried to use CA9 to improve the differential diagnosis of kidney tumors using tumor biopsy or fine needle aspiration. More recently, the investigators have developed the ELISA and quantitative reat time polymerase chain reaction (RT-PCR) to study the CA9 protein and CA9 mRNA in the serum of patients with non-metastatic kidney cancer. The investigators have thus shown that CA9 was overexpressed prior to surgery and that this expression disappeared after tumor ablation.

详细描述

We propose a pilot study of CA9 serum in patients with adenocarcinoma metastatic cell treated by conventional immunotherapy and / or targeted therapy. This pilot study aims to test the CA9 serum marker of response to medical treatment

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

  • Conventional renal cell cancer with a pathological diagnosis
  • Metastatic disease
  • Consent form signed
  • social security regimen affiliated

排除标准

  • Other cancer treated

结局指标

主要结局

serum protein CA9 and mRNA CA9 level under medical treatment

时间窗: before treatment, at 1, 3, 6, 9 and 12 months

次要结局

  • The type and duration of clinical response based on the initial rate and the slope of decline(Before treatment, at 1, 3, 6, 9, and 12 months)
  • Correlation clinical response (complete response, partial response, stabilization, progression)-evolution serum CA9 level in blood and urine(Before treatment, at 1, 3, 6, 9, and 12 months)
  • serum CA9 level basis and during the following treatment groups of the MSKCC prognostic(Before treatment, at 1, 3, 6, 9, and 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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