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临床试验/NCT04377113
NCT04377113已完成不适用

NK Cells, Tumor Infiltrating Lymphocytes and Cell Cytotoxicity in Renal Cell Cancer - Observational Study

Clinical Hospital Center Rijeka1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年5月24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
Distribution of immune cells between two groups measured in the blood samples

研究概览

简要总结

Renal cell cancer (RCC) is one of the most important urogenital tumors because of it's high mortality and increasing incidence. RCC, which accounts about 3% of all malignant tumors in the adults, is the most lethal urogenital cancer. The high mortality rate stimulate investigator groups to study RCC pathogenesis including immunological part. It is interesting that immunotherapy was firstly started in patients with metastatic RCC using IL-2 and interferon gamma. The first results were promising but the exact mechanism of acting was not found. In the RCC, as in the others tumors, immune cells (T lymphocytes, NK and NKT cells) are responsible for main antitumor effect. Their effect was caused by cytotoxic activity on the tumor cells. In the investigation investigators will determine patterns of aggregation of tumor infiltrating immune cells in the blood, healthy kidney and carcinomatous tissue. But, presence of this cells not implicated that this cells are active. Their activity will be determined by proofing cytotoxicity of different subgroup of immune cells. In that way investigators will present different patterns of aggregation of tumor infiltrating immune cells and their cytotoxicity which will direct that this cells are active with antitumor effect. Correlation of collected data with classical prognostic factors in the patients with RCC as tumor staging, tumor grading (Fuhrman) and histological subtype will help to determine some immunological factors as possible new prognostic factors. For conclusion, the results of this study will allow better understanding of RCC pathogenesis, specially their immunological part and become a foundation for the future investigations.

详细描述

Cellular immunity will be investigated in the two group of patients: operated patients with RCC and healthy volunteers.

In the study investigators will determine patterns of aggregation of tumor infiltrating immune cells in the blood (RCC patients and volunteers), healthy kidney and carcinomatous tissue as their cytotoxicity (only RCC patients).

Investigators will determine:

  1. presence of different immune cells in the blood and kidney tissue (T lymphocytes, NK cells, NKT cells, T regulatory cells),
  2. presence and distribution of cytolytic molecule perforin and granulysin in immune cells (T lymphocytes, NK cells, NKT cells) in the blood, kidney tissue and urine
  3. NK cytotoxicity
  4. possible correlation between presence of immune cells and clinical prognostic factors

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

  • RCC (renal cell cancer) patients
  • operated patients
  • both gender
  • older than 18 years
  • written informed consent

排除标准

  • age younger of 18
  • patients with metastatic disease
  • patients receiving antibiotics 6 weeks before operation
  • patients regularly treated with corticosteroids or immunosuppressive drugs
  • transplanted patients
  • patients with autoimmune diseases and/or vasculitis

结局指标

主要结局

Distribution of immune cells between two groups measured in the blood samples

时间窗: 7 months

Determination of distribution of immune cells between two groups in their blood samples with their comparison.

Determination of NK cytotoxicity

时间窗: 7 months

Determination of NK cytotoxicity

Distribution of immune cells between different tissue samples (RCC vs. healthy tissue vs. borderline tissue)

时间窗: 7 months

Determination of distribution of immune cells between different tissue samples with their comparison

次要结局

未报告次要终点

研究者

发起方
Clinical Hospital Center Rijeka
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dean Markic

Prof. of Urology, MD, PhD, FEBU

Clinical Hospital Center Rijeka

研究点 (1)

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