Studying Tumor Tissue Samples From Patients Who Have Undergone Surgery for Localized Kidney Cancer

Kidney Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00908739
• Other study ID #: CASE1808
• Secondary ID: P30CA043703CASE1
• Status: Withdrawn
• Phase: N/A
• First received: May 23, 2009
• Last updated: September 29, 2015
• Start date: May 2008

Study information

• Verified date: September 2015
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical 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.

PURPOSE: This research study is looking at tumor tissue samples from patients who have undergone surgery for localized kidney cancer.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Genetic:
• gene expression analysis
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)

Other:
• immunohistochemistry staining method
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 analysis
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)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative patterns of expression/activity of five different growth factors/enzymes inherently related to the development of metastatic renal cell carcinoma behavior			No