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Cellular Immunity and Renal Cell Cancer

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04377113
Enrollment
60
Registered
2020-05-06
Start date
2020-05-24
Completion date
2021-07-26
Last updated
2021-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Cancer, NK Cell Cytokine Production, NK Cell Mediated Immunity

Keywords

renal cell cancer, NK cells, tumor infiltrating lymphocytes, cellular immunity

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

Interventions

None listed

Sponsors

Clinical Hospital Center Rijeka
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Distribution of immune cells between two groups measured in the blood samples7 monthsDetermination of distribution of immune cells between two groups in their blood samples with their comparison.
Distribution of immune cells between different tissue samples (RCC vs. healthy tissue vs. borderline tissue)7 monthsDetermination of distribution of immune cells between different tissue samples with their comparison
Determination of NK cytotoxicity7 monthsDetermination of NK cytotoxicity

Countries

Croatia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026