Studying Biomarkers in Samples From Younger Patients With Kidney Cancer

August 3, 2018 updated by: Children's Oncology Group

Focal Adhesion Kinase Expression in Pediatric Renal Tumors

This laboratory study is looking into biomarkers in samples from younger patients with kidney cancer. Studying samples of 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. It may also help doctors find better ways to treat cancer.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To determine whether focal adhesion kinase (FAK) is expressed and if FAK is phosphorylated in pediatric renal tumors.

OUTLINE:

Archived tumor tissue samples are analyzed for FAK expression by immunohistochemistry (IHC). IHC staining is compared in normal renal tissue, Wilms tumor (routine and anaplastic), malignant rhabdoid tumor of the kidney, clear cell sarcoma of the kidney, and mesoblastic nephroma.

Study Type

Observational

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
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Childrens Oncology Group

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Description

Inclusion Criteria:

  • Formalin-fixed, paraffin-embedded tissue samples from patients diagnosed with the following renal tumors:

    • Anaplastic Wilms tumor
    • Malignant rhabdoid tumor of the kidney
    • Clear cell sarcoma of the kidney
    • Mesoblastic nephroma

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
Intervention / Treatment
Basic science (FAK expression)
Archived tumor tissue samples are analyzed for FAK expression by IHC. IHC staining is compared in normal renal tissue, Wilms tumor (routine and anaplastic), malignant rhabdoid tumor of the kidney, clear cell sarcoma of the kidney, and mesoblastic nephroma.
Other: Laboratory Biomarker Analysis
Correlative studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
FAK expression in pediatric renal tumors
Time Frame: Baseline
Baseline

Collaborators and Investigators

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

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Elizabeth Beierle, Children's Oncology Group

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 (Actual)

August 22, 2012

Primary Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

July 15, 2012

First Submitted That Met QC Criteria

July 15, 2012

First Posted (Estimate)

July 17, 2012

Study Record Updates

Last Update Posted (Actual)

August 7, 2018

Last Update Submitted That Met QC Criteria

August 3, 2018

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AREN12B8 (Other Identifier: CTEP)
  • NCI-2012-01987 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • CDR0000736805
  • COG-AREN12B8

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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