Cellular Immunity and Renal Cell Cancer

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.

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Key information

Conditions

NK Cell Mediated Immunity Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Cancer Kidney Diseases Kidney Neoplasms Male Urogenital Diseases NK Cell Cytokine Production Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Hospital Center Rijeka

Rijeka, 51 000, Croatia

About this study

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:

presence of different immune cells in the blood and kidney tissue (T lymphocytes, NK cells, NKT cells, T regulatory cells),
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
NK cytotoxicity
possible correlation between presence of immune cells and clinical prognostic factors

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Time frame: 7 months

Determination 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)

Time frame: 7 months

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

Time frame: 7 months

Determination of NK cytotoxicity

Sponsors and collaborators

Lead sponsor

Clinical Hospital Center Rijeka

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: May 6, 2020
Registry last updated: Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed