Gene Expression in Normal Tissue and Tumor Tissue From Patients Who Have Undergone Surgery For Kidney Cancer

May 25, 2017 updated by: Wake Forest University Health Sciences

Renal Cell Cancer Tumor Markers

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.

Study Overview

Status

Terminated

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157-1096
        • Wake Forest University Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Those wiht histologically confirmed renal cell cancer who have underwent nephrectomy for renal cell cancer.

Description

Inclusion Criteria:

  • Histologically confirmed renal cell cancer
  • Clinical staging (if available)
  • Underwent nephrectomy for renal cell cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
patients with renal cell cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Expression levels of novel genes and proteins (HFARP, HAMGR28, HE9NG77) in frozen normal tissue and tumor tissue
Time Frame: day 1
day 1
Correlation of gene and protein expression levels with disease stage, tumor size, and pathology reports
Time Frame: day 1
day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: day 1
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Frank M. Torti, MD, MPH, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 25, 2017

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000550079
  • P30CA012197 (U.S. NIH Grant/Contract)
  • CCCWFU-89A03
  • CCCWFU-GB03-404

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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