Value of Various Chemokines in the Detection and Follow up of RCC

March 4, 2015 updated by: Boris Friedman, Carmel Medical Center
This study was designed as a pilot study to try and find a Chemokine that may be specific for renal cell carcinoma

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

I n previous studies that were initiated in experimental models of different inflammatory autoimmune diseases and then extended to humans, we have shown that in the course of inflammatory autoimmune diseases, the immune system selectively generates an auto-Ab response to a few inflammatory mediators, mostly chemokines and cytokines, which are thought to participate in promoting the inflammatory process (1-6). For example, we showed that patients suffering from rheumatoid arthritis (RA) but not osteoarthritis display a significant level of neutralizing auto- Abs directed against TNF-a (tumor necrosis factor)(3). These patients did not mount any auto-Ab response either to several key inflammatory chemokines or to regulatory mediators, such as IL-10(interleukin-10) or TGF-b(tumor growth factor)(, or even the chemokine CXCL12(C-X-C motif chemokine 12), which also functions as a regulatory mediator that selects Ag-specific IL-10-producing CD4+(cluster of differentiation 4) T cells (7).

Complementary experiments suggested that in experimentally induced RA, these anti-TNF-a auto-Abs participate in the natural regulation of disease and restrain-although they are incapable of totally preventing-its development (3). Nevertheless, their selective amplification by targeted DNA vaccines led to rapid recovery from an ongoing disease (8). These studies also showed that selective breakdown of tolerance to TNF-a is due to its preferential expression at a partially immune-restricted site undergoing a destructive process (3, 8). Very recently, we have shown that type I diabetes mellitus (T1DM) patients preferentially display auto-Ab production to CCL3( Chemokine (C-C motif) ligand 3) and not to several other proinflammatory chemokines (9).

It is yet to be proven that this chemokine dominates the chemokine expression at the autoimmune site. Nevertheless, a previous study showing that selective neutralization of CCL3 suppresses T1DM in NOD mice has implications for the important role of this chemokine in this disease (10). Similarly to organ-specific autoimmunity in various cancer diseases, one of which is cancer of the prostate (CaP), key inflammatory chemokines are expressed at the primary tumor site, which also undergoes a destructive process at a restricted site. In a previous study we showed that in primary tumor sections of prostate cancer subjects, CCL2Chemokine (C-C motif) ligand 2) is predominantly expressed at the tumor site over other chemokines that also have been associated with tumor development, including: CXCL12, CXCL10, CXCL8, CCL3,CCL4, and CCL5. Subsequently, the immune response selectivity mounts an Ab-based response to CCL2. These Abs are neutralizing Abs. These findings hold diagnostic and therapeutic implications.

Little is known about the possible function of chemokine receptors in the development and progression of renal cell carcinoma (RCC). Few studies exist dealing with gene expression of chemokines in RCC. We therefore suggest a study checking antibody response to a few chemokines

Study Type

Observational

Enrollment (Anticipated)

30

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

  • Israel
      • Haifa, Israel, 34362
        • Recruiting
        • Carmel Medical Center
        • Contact:
        • Principal Investigator:
          • Boris Friedman, M.D.
        • Sub-Investigator:
          • Yoram Dekel, M.D.
        • Sub-Investigator:
          • Avi Stein, M.D.
        • Sub-Investigator:
          • Yuval Friefeld, M.D.
        • Sub-Investigator:
          • Gazi Fares, M.D.
        • Sub-Investigator:
          • Alexander Kaploon, M.D.
        • Sub-Investigator:
          • Leonid Boyarsky, M.D.
        • Sub-Investigator:
          • Yoel Metz, M.D.

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

20 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients scheduled for partial or radical nephrectomy

Description

Inclusion Criteria:

Patients with renal cell carcinoma of one or both kidneys scheduled for surgical resection

-

Exclusion Criteria:

Males with elevated PSA (prostatic specific antigen ) Any other untreated malignancy -

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
Intervention / Treatment
Renal cell carcinoma
Patients with renal cell carcinoma scheduled for partial or radical nephrectomy
Other: patients with renal cell carcinoma
Chemokines that may be elevated in patients with RCC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurement of the titers of chemokines before and after tumor resection
Time Frame: before nephrectomy (day of surgery)
before nephrectomy (day of surgery)

Collaborators and Investigators

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

Sponsor

Carmel Medical Center

Investigators

  • Principal Investigator: Avi Stein, M.D., Carmel Medical Center

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

January 1, 2014

Primary Completion (ANTICIPATED)

November 1, 2016

Study Completion (ANTICIPATED)

November 1, 2016

Study Registration Dates

First Submitted

October 30, 2013

First Submitted That Met QC Criteria

December 27, 2013

First Posted (ESTIMATE)

December 30, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 5, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMC-13-0064-CTIL
  • CMC-13-0064 (REGISTRY: Title: Chemokines and RCC)

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.

Clinical Trials on Clear Cell Renal Cell Carcinoma

Clinical Trials on patients with renal cell carcinoma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe