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Clear Cell Renal Cell CarcinomaNCT02022787

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

An observational study of Clear Cell Renal Cell Carcinoma, run by Carmel Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study was designed as a pilot study to try and find a Chemokine that may be specific for renal cell carcinoma Read more about this study

Who is it for?
Ages 20 to 90 years
Conditions the study is for
Clear Cell Renal Cell Carcinoma
What is being tested?
patients with renal cell carcinoma
How many people
30 participants
Where
1 siteIsrael
Study dates
Jan 2014to Nov 2016
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 20 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients scheduled for partial or radical nephrectomy

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Israel1 site, 1 recruiting
  • Carmel Medical Center

    Haifa, 34362

    Avi Stein, M.D., 9728250843, stein6996@gmail.com

    Boris Friedman, M.D.

    Recruiting

Other trials in Israel

About this study

This study was designed as a pilot study to try and find a Chemokine that may be specific for renal cell carcinoma

Read the 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

Being tested
patients with renal cell carcinoma
Keywords
RCC, Chemokines, nephrectomy, partial nephrectomy
Medical subject headings
Carcinoma, Renal Cell

What participants receive

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

  • patients with renal cell carcinomaOther

    Chemokines that may be elevated in patients with RCC

Study groups in NCT02022787
Study groupRoleWhat they receive
Renal cell carcinomaPatients with renal cell carcinoma scheduled for partial or radical nephrectomy
Receives: Other: patients with renal cell carcinoma

What is being measured

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

  1. Measurement of the titers of chemokines before and after tumor resection

    Measured: before nephrectomy (day of surgery)

Timeline

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

  1. First posted30 Dec 2013 (estimated)
  2. Study startJan 2014
  3. Primary completionNov 2016 (estimated)
  4. Study completionNov 2016 (estimated)

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
Case-control
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02022787
Sponsor's protocol ID
CMC-13-0064-CTIL
Other IDs
CMC-13-0064
Status last verified
Mar 2015
First submitted
30 Oct 2013
Last updated
5 Mar 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Clear Cell Renal Cell Carcinoma, run by Carmel Medical Center at 1 site in Israel.

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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Mar 2015. 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 Israel. 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?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of the titers of chemokines before and after tumor resection (time frame: before nephrectomy (day of surgery)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 5 Mar 2015.

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