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.
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
- Recruiting
Carmel Medical Center
Haifa, 34362
Avi Stein, M.D., 9728250843, stein6996@gmail.com
Boris Friedman, M.D.
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
- Conditions
- Clear Cell Renal Cell Carcinoma
- 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 group | Role | What they receive |
|---|---|---|
| Renal cell carcinoma | Patients 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.
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.
- First posted30 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clear Cell Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boris Friedman, Carmel Medical Center
- Investigators
- Avi Stein, M.D., Principal investigator, Carmel Medical Center
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Various Chemokines in the Detection and Follow up of RCC
- ClinicalTrials.gov ID
- NCT02022787
- Acronym / sponsor ID
- CMC-13-0064-CTIL
- Conditions
- Clear Cell Renal Cell Carcinoma
- Keywords
- RCC, Chemokines, nephrectomy, partial nephrectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 30 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed as a pilot study to try and find a Chemokine that may be specific for renal cell carcinoma
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal cell carcinoma | – | Other: patients with renal cell carcinomaPatients with renal cell carcinoma scheduled for partial or radical nephrectomy |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for partial or radical nephrectomy
Key inclusion criteria (2 listed)
- Patients with renal cell carcinoma of one or both kidneys scheduled for surgical resection
- -
Key exclusion criteria (1 listed)
- Males with elevated PSA (prostatic specific antigen ) Any other untreated malignancy -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patients with renal cell carcinomaChemokines that may be elevated in patients with RCC | Other | Renal cell carcinoma |
Primary outcome
Measurement of the titers of chemokines before and after tumor resection
Time frame: before nephrectomy (day of surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Avi Stein, M.D. principal investigator
Carmel Medical Center
1 site in 1 country: see every site and its status.
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.