Cellular Immunity and Renal Cell Cancer

NCT ID: NCT04377113

Last Updated: 2021-09-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-24
• Study Completion Date: 2021-07-26

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

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

RCC patients

RCC patients (30 pts) will include patients with kidney cancer (renal cell cancer).

Investigators will collect and analyze:

• blood sample,
• urine sample,
• kidney tissue sample (healthy tissue, carcinomatous tissue and borderline tissue between them).

No interventions assigned to this group

Healthy patients

In this group (30 patients) will be recruiting healthy patients (volunteer).

Investigators will collect and analyze:

• blood sample.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Clinical Hospital Center Rijeka

OTHER

Sponsor Role: lead

Responsible Party

Dean Markic

Prof. of Urology, MD, PhD, FEBU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dean Markić, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Hospital Center Rijeka

Locations

Clinical Hospital Center Rijeka

Rijeka, , Croatia

Countries

Croatia

References

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Other Identifiers

31052020

Identifier Type: -

Identifier Source: org_study_id