Clinical trial · Observational
Cellular Immunity and Renal Cell Cancer
NK Cells, Tumor Infiltrating Lymphocytes and Cell Cytotoxicity in Renal Cell Cancer - Observational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| NK Cell Cytokine Production | — | UNRESOLVED | — |
| NK Cell Mediated Immunity | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- RCC patients
- description
- 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).
- label
- Healthy patients
- description
- In this group (30 patients) will be recruiting healthy patients (volunteer). Investigators will collect and analyze: * blood sample.
Primary outcomes (3)
- measure
- Distribution of immune cells between two groups measured in the blood samples
- timeFrame
- 7 months
- description
- Determination of distribution of immune cells between two groups in their blood samples with their comparison.
- measure
- Distribution of immune cells between different tissue samples (RCC vs. healthy tissue vs. borderline tissue)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (9)
- BACKGROUNDSotosek S, Sotosek Tokmadzic V, Mrakovcic-Sutic I, Tomas MI, Dominovic M, Tulic V, Sutic I, Maricic A, Sokolic J, Sustic A. Comparative study of frequency of different lymphocytes subpopulation in peripheral blood of patients with prostate cancer and benign prostatic hyperplasia. Wien Klin Wochenschr. 2011 Dec;123(23-24):718-25. doi: 10.1007/s00508-011-0096-7. Epub 2011 Nov 23. PMID 22105113
- BACKGROUNDSotosek Tokmadzic V, Laskarin G, Mahmutefendic H, Lucin P, Mrakovcic-Sutic I, Zupan Z, Sustic A. Expression of cytolytic protein-perforin in peripheral blood lymphocytes in severe traumatic brain injured patients. Injury. 2012 May;43(5):624-31. doi: 10.1016/j.injury.2010.05.009. Epub 2010 May 26. PMID 20537642
- BACKGROUNDMrakovcic-Sutic I, Bacic D, Golubovic S, Bacic R, Marinovic M. Cross-talk between NKT and regulatory T cells (Tregs) in modulation of immune response in patients with colorectal cancer following different pain management techniques. Coll Antropol. 2011 Sep;35 Suppl 2:57-60. PMID 22220404
- BACKGROUNDXia Y, Zhang Q, Zhen Q, Zhao Y, Liu N, Li T, Hao Y, Zhang Y, Luo C, Wu X. Negative regulation of tumor-infiltrating NK cell in clear cell renal cell carcinoma patients through the exosomal pathway. Oncotarget. 2017 Jun 6;8(23):37783-37795. doi: 10.18632/oncotarget.16354. PMID 28384121
- BACKGROUNDCozar JM, Canton J, Tallada M, Concha A, Cabrera T, Garrido F, Ruiz-Cabello Osuna F. Analysis of NK cells and chemokine receptors in tumor infiltrating CD4 T lymphocytes in human renal carcinomas. Cancer Immunol Immunother. 2005 Sep;54(9):858-66. doi: 10.1007/s00262-004-0646-1. Epub 2005 May 11. PMID 15887015
- BACKGROUNDShabtai M, Ye H, Frischer Z, Martin J, Waltzer WC, Malinowski K. Increased expression of activation markers in renal cell carcinoma infiltrating lymphocytes. J Urol. 2002 Nov;168(5):2216-9. doi: 10.1016/S0022-5347(05)64358-3. PMID 12394762