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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00899860
Other study ID # CDR0000550079
Secondary ID P30CA012197CCCWF
Status Terminated
Phase N/A
First received May 9, 2009
Last updated May 25, 2017
Start date September 2003
Est. completion date June 2012

Study information

Verified date June 2012
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

RATIONALE: Studying the genes and proteins expressed in tissue samples from patients with cancer may help doctors identify biomarkers related to cancer.

PURPOSE: This laboratory study is evaluating gene and protein expression in normal tissue and tumor tissue from patients who have undergone surgery for kidney cancer.


Description:

OBJECTIVES:

Primary

- Determine the expression levels of novel genes and proteins (HFARP, HAMGR28, HE9NG77) in frozen normal tissue and tumor tissue samples from patients who have undergone nephrectomy for renal cell cancer.

- Correlate gene and protein expression levels with disease stage, tumor size, and pathology reports (e.g., cell type, grade, and tissue architecture) in order to evaluate the rate of gene and protein expression as targets for future therapeutic interventions.

Secondary

- Compare proteomic screening of potential biomarkers using existing plasma and/or urine samples from patients with renal cell cancer or breast cancer stored in the CCCWFU Tumor Tissue Core with tissue samples from patients enrolled in this study.

OUTLINE: Normal and tumor tissue collected from patients who have undergone nephrectomy and diagnostic and therapeutic intervention for renal cell cancer is analyzed for histopathological expression and compared to normal kidney cells by northern blot. Tissue samples are evaluated by RNA and protein extraction and analyzed by gel electrophoresis, blotting, and phosphor-imaging for induction or suppression of genes and protein levels. These data are correlated with clinical stage, tumor size, and histopathological grade and architecture of the patient's disease.


Recruitment information / eligibility

Status Terminated
Enrollment 30
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender All
Age group N/A to 120 Years
Eligibility Inclusion Criteria:

- Histologically confirmed renal cell cancer

- Clinical staging (if available)

- Underwent nephrectomy for renal cell cancer

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Wake Forest University Health Sciences National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Expression levels of novel genes and proteins (HFARP, HAMGR28, HE9NG77) in frozen normal tissue and tumor tissue day 1
Primary Correlation of gene and protein expression levels with disease stage, tumor size, and pathology reports day 1
Secondary Comparison of proteomic screening of potential biomarkers using plasma and/or urine samples from patients with renal cell cancer or breast cancer stored in the CCCWFU Tumor Tissue Core with tissue samples from patients enrolled in this study day 1
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