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AzTrials

NK Cell Mediated ImmunityNCT04377113

Cellular Immunity and Renal Cell Cancer

An observational study of NK Cell Mediated Immunity and NK Cell Cytokine Production, run by Clinical Hospital Center Rijeka at 1 site in Croatia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
How many people
60 participants
Where
1 siteCroatia
Study dates
24 May 2020to 26 Jul 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Two groups of the patients: 1. Patients operated because of RCC (30 patients) 2. Healthy volunteers (30 patients)

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Croatia1 site

  • Clinical Hospital Center Rijeka

    Rijeka, 51 000

Other trials in Croatia

About this study

Official title: 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.

Read the 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
Keywords
renal cell cancer, NK cells, tumor infiltrating lymphocytes, cellular immunity
Medical subject headings
Kidney Neoplasms, Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04377113
Study groupRoleWhat they receive
RCC patientsRCC 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 patientsIn this group (30 patients) will be recruiting healthy patients (volunteer). Investigators will collect and analyze: * blood sample.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 7 months

  2. 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

    Measured: 7 months

  3. Determination of NK cytotoxicity

    Determination of NK cytotoxicity

    Measured: 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2020
  2. Study start24 May 2020
  3. Primary completion26 Jul 2021
  4. Study completion26 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04377113
Sponsor's protocol ID
31052020
Status last verified
May 2020
First submitted
3 May 2020
Last updated
21 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: All included patients will signed informed consent. Individual participant data will not be shared with other researchers.

Publications

  • 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.

    PubMed 22105113

  • 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.

    PubMed 20537642

  • 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.

    PubMed 22220404

  • 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.

    PubMed 28384121

  • 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.

    PubMed 15887015

  • 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.

    PubMed 12394762

  • 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.

    PubMed 25637538

  • 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.

    PubMed 22079021

  • 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.

    PubMed 2972244

Questions about this trial

What is this clinical trial studying?

An observational study of NK Cell Mediated Immunity and NK Cell Cytokine Production, run by Clinical Hospital Center Rijeka at 1 site in Croatia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Distribution of immune cells between two groups measured in the blood samples (time frame: 7 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04377113, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.

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