Kidney CancerNCT00908739
Studying Tumor Tissue Samples From Patients Who Have Undergone Surgery for Localized Kidney Cancer
An observational study of Kidney Cancer, run by Case Comprehensive Cancer Center.
Trial summary
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- gene expression analysis, immunohistochemistry staining method and laboratory biomarker analysis
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2008to Sep 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Primary care clinic
DISEASE CHARACTERISTICS:
- Tumor tissue samples from patients who recently underwent nephrectomy or partial nephrectomy for clear cell renal cell carcinoma
- Harvested from the superior, inferior, left lateral, right lateral, and central portions of resected or discarded tumor measuring 4 cm or less
- Localized disease (pT1a, N0-Nx, M0)
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: Assessment of Patterns of Expression of VEGF, Matrix Metalloproteinase 2, 9 Activity, E-Cadherin Regulation and CA-9 Activity as Predictors of Aggressive Renal Cell Carcinoma Behavior
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at tumor tissue samples from patients who have undergone surgery for localized kidney cancer.
Read the detailed description
OBJECTIVES:
- To identify consistent patterns of VEGF expression, E-cadherin regulation, matrix metalloproteinase 2 and 9 activity, and carbonic anhydrase 9 activity as predictive factors in the development of aggressive tumor behavior in tumor tissue samples from patients with localized clear cell renal cell carcinoma.
OUTLINE: Previously collected tumor tissue samples are examined by immunohistochemistry for levels of expression of five different factors related to aggressive tumor behavior (i.e., VEGF expression, E-cadherin regulation, matrix metalloproteinase 2 and 9 activity, and carbonic anhydrase 9 activity). Samples are compared to positive tissue controls (i.e., VEGF- tonsil; E- cadherin-normal breast or endometrium; MMP2- placenta) and a negative control (i.e., isotype matched normal serum) to identify consistent patterns of expression/activity of these factors. Levels of expression are quantified as 5-level scores (0 to 4 scale) and differences between any two areas of a tumor are analyzed.
- Conditions
- Kidney Cancer
- Being tested
- gene expression analysis, immunohistochemistry staining method, laboratory biomarker analysis
- Keywords
- stage I renal cell cancer, stage III renal cell cancer, recurrent renal cell cancer, clear cell renal cell carcinoma, childhood renal cell carcinoma
- 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.
gene expression analysisGenetic
immunohistochemistry for levels of expression of five different factors related to aggressive tumor behavior (i.e., VEGF expression, E-cadherin regulation, matrix metalloproteinase 2 and 9 activity, and carbonic anhydrase 9 activity)
immunohistochemistry staining methodOther
immunohistochemistry for levels of expression of five different factors related to aggressive tumor behavior (i.e., VEGF expression, E-cadherin regulation, matrix metalloproteinase 2 and 9 activity, and carbonic anhydrase 9 activity)
laboratory biomarker analysisOther
immunohistochemistry for levels of expression of five different factors related to aggressive tumor behavior (i.e., VEGF expression, E-cadherin regulation, matrix metalloproteinase 2 and 9 activity, and carbonic anhydrase 9 activity)
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative patterns of expression/activity of five different growth factors/enzymes inherently related to the development of metastatic renal cell carcinoma behavior
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2009 (estimated)
- Study startMay 2008
- Primary completionSep 2008
Why it stopped: PI left
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- David A. Levy, MD, Principal investigator, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908739
- Sponsor's protocol ID
- CASE1808
- Other IDs
- P30CA043703, CASE1808, CASE-1808-CC503
- Status last verified
- Sep 2015
- First submitted
- 23 May 2009
- Last updated
- 30 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Patterns of Expression of VEGF, Matrix Metalloproteinase 2, 9 Activity, E-Cadherin Regulation and CA-9 Activity as Predictors of Aggressive Renal Cell Carcinoma Behavior
- ClinicalTrials.gov ID
- NCT00908739
- Acronym / sponsor ID
- CASE1808
- Conditions
- Kidney Cancer
- Keywords
- stage I renal cell cancer, stage III renal cell cancer, recurrent renal cell cancer, clear cell renal cell carcinoma, childhood renal cell carcinoma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI left
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2008
- Primary completion
- Sep 2008 (actual)
- First posted
- 27 May 2009 (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.
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at tumor tissue samples from patients who have undergone surgery for localized kidney cancer.
Detailed description
OBJECTIVES:
- To identify consistent patterns of VEGF expression, E-cadherin regulation, matrix metalloproteinase 2 and 9 activity, and carbonic anhydrase 9 activity as predictive factors in the development of aggressive tumor behavior in tumor tissue samples from patients with localized clear cell renal cell carcinoma.
OUTLINE: Previously collected tumor tissue samples are examined by immunohistochemistry for levels of expression of five different factors related to aggressive tumor behavior (i.e., VEGF expression, E-cadherin regulation, matrix metalloproteinase 2 and 9 activity, and carbonic anhydrase 9 activity). Samples are compared to positive tissue controls (i.e., VEGF- tonsil; E- cadherin-normal breast or endometrium; MMP2- placenta) and a negative control (i.e., isotype matched normal serum) to identify consistent patterns of expression/activity of these factors. Levels of expression are quantified as 5-level scores (0 to 4 scale) and differences between any two areas of a tumor are analyzed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary care clinic
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 |
|---|---|---|
| gene expression analysisimmunohistochemistry for levels of expression of five different factors related to aggressive tumor behavior (i.e., VEGF expression, E-cadherin regulation, matrix metalloproteinase 2 and 9 activity, and carbonic anhydrase 9 activity) | Genetic | – |
| immunohistochemistry staining methodimmunohistochemistry for levels of expression of five different factors related to aggressive tumor behavior (i.e., VEGF expression, E-cadherin regulation, matrix metalloproteinase 2 and 9 activity, and carbonic anhydrase 9 activity) | Other | – |
| laboratory biomarker analysisimmunohistochemistry for levels of expression of five different factors related to aggressive tumor behavior (i.e., VEGF expression, E-cadherin regulation, matrix metalloproteinase 2 and 9 activity, and carbonic anhydrase 9 activity) | Other | – |
Primary outcome
Relative patterns of expression/activity of five different growth factors/enzymes inherently related to the development of metastatic renal cell carcinoma behavior
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 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.
David A. Levy, MD principal investigator
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Cancer, run by Case Comprehensive Cancer Center.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Relative patterns of expression/activity of five different growth factors/enzymes inherently related to the development of metastatic renal cell carcinoma behavior. 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 30 Sep 2015.