Cellular Immunity and Renal Cell Cancer
- Conditions
- NK Cell Mediated ImmunityKidney CancerNK Cell Cytokine Production
- Registration Number
- NCT04377113
- Lead Sponsor
- Clinical Hospital Center Rijeka
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- RCC (renal cell cancer) patients
- operated patients
- both gender
- older than 18 years
- written informed consent
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Distribution of immune cells between two groups measured in the blood samples 7 months Determination of distribution of immune cells between two groups in their blood samples with their comparison.
Determination of NK cytotoxicity 7 months Determination of NK cytotoxicity
Distribution of immune cells between different tissue samples (RCC vs. healthy tissue vs. borderline tissue) 7 months Determination of distribution of immune cells between different tissue samples with their comparison
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Hospital Center Rijeka
ðŸ‡ðŸ‡·Rijeka, Croatia