Cellular Immunity and Renal Cell Cancer

NCT04377113 | Completed

• 1 other identifier: 31052020
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

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

  Determination of distribution of immune cells between two groups in their blood samples with their comparison.

  7 months

• Distribution of immune cells between different tissue samples (RCC vs. healthy tissue vs. borderline tissue)

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

  7 months

• Determination of NK cytotoxicity

  Determination of NK cytotoxicity

  7 months

Study Arms (2)

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).

Healthy patients

In this group (30 patients) will be recruiting healthy patients (volunteer). Investigators will collect and analyze: * blood sample.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Hospital Center Rijeka: lead

Study Sites (1)

Clinical Hospital Center Rijeka

Rijeka, 51 000, Croatia

Location

Related Publications (9)

• Sotosek 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 BACKGROUND

• Sotosek 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 BACKGROUND

• Mrakovcic-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 BACKGROUND

• Xia 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 BACKGROUND

• Cozar 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 BACKGROUND

• Shabtai 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 BACKGROUND

• Zhang Q, Jia Q, Deng T, Song B, Li L. Heterogeneous expansion of CD4+ tumor-infiltrating T-lymphocytes in clear cell renal cell carcinomas. Biochem Biophys Res Commun. 2015 Feb 27;458(1):70-6. doi: 10.1016/j.bbrc.2015.01.069. Epub 2015 Jan 28.

  PMID: 25637538 BACKGROUND

• Oldham KA, Parsonage G, Bhatt RI, Wallace DM, Deshmukh N, Chaudhri S, Adams DH, Lee SP. T lymphocyte recruitment into renal cell carcinoma tissue: a role for chemokine receptors CXCR3, CXCR6, CCR5, and CCR6. Eur Urol. 2012 Feb;61(2):385-94. doi: 10.1016/j.eururo.2011.10.035. Epub 2011 Nov 4.

  PMID: 22079021 BACKGROUND

• Finke JH, Tubbs R, Connelly B, Pontes E, Montie J. Tumor-infiltrating lymphocytes in patients with renal-cell carcinoma. Ann N Y Acad Sci. 1988;532:387-94. doi: 10.1111/j.1749-6632.1988.tb36356.x. No abstract available.

  PMID: 2972244 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Investigators will collect: 1. patients with kidney cancer: * blood, * urine, * kidney tissue removed during operation (healthy kidney tissue, carcinomatous tissue and tissue form the border) 2. healthy control: * blood

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Dean Markić, MD, PhD

  Clinical Hospital Center Rijeka

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. of Urology, MD, PhD, FEBU

Study Record Dates

• First Submitted: May 3, 2020
• First Posted: May 6, 2020
• Study Start: May 24, 2020
• Primary Completion: July 26, 2021
• Study Completion: July 26, 2021
• Last Updated: September 21, 2021

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)