Clinical trial NCT04377113: Cellular Immunity and Renal Cell Cancer
Official title: NK Cells, Tumor Infiltrating Lymphocytes and Cell Cytotoxicity in Renal Cell Cancer - Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: NK Cell Mediated Immunity
NK Cell Cytokine Production
Kidney Cancer
Keywords: renal cell cancer
NK cells
tumor infiltrating lymphocytes
cellular immunity
Lead sponsor: Clinical Hospital Center Rijeka
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Two groups of the patients:

1. Patients operated because of RCC (30 patients)
2. Healthy volunteers (30 patients)

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

Eligibility criteria: 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

Primary outcomes:
measure: Distribution of immune cells between two groups measured in the blood samples
timeFrame: 7 months
measure: Distribution of immune cells between different tissue samples (RCC vs. healthy tissue vs. borderline tissue)
timeFrame: 7 months
measure: Determination of NK cytotoxicity
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rijeka
country: Croatia
facility: Clinical Hospital Center Rijeka
Study officials:
affiliation: Clinical Hospital Center Rijeka
name: Dean Markić, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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