Cellular Immunity and Renal Cell Cancer

September 19, 2021 updated by: Dean Markic, Clinical Hospital Center Rijeka

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

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.

Study Overview

Status

Completed

Conditions

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

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Rijeka, Croatia, 51 000
        • Clinical Hospital Center Rijeka

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 months
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
7 months
Determination of NK cytotoxicity
Time Frame: 7 months
Determination of NK cytotoxicity
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Hospital Center Rijeka

Investigators

  • Principal Investigator: Dean Markić, MD, PhD, Clinical Hospital Center Rijeka

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2020

Primary Completion (Actual)

July 26, 2021

Study Completion (Actual)

July 26, 2021

Study Registration Dates

First Submitted

May 3, 2020

First Submitted That Met QC Criteria

May 3, 2020

First Posted (Actual)

May 6, 2020

Study Record Updates

Last Update Posted (Actual)

September 21, 2021

Last Update Submitted That Met QC Criteria

September 19, 2021

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31052020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All included patients will signed informed consent. Individual participant data will not be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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