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Studying Biomarkers in Samples From Younger Patients With Kidney Cancer

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ClinicalTrials.gov Identifier: NCT01642095
Recruitment Status : Withdrawn
First Posted : July 17, 2012
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Tracking Information
First Submitted Date July 15, 2012
First Posted Date July 17, 2012
Last Update Posted Date August 7, 2018
Actual Study Start Date August 22, 2012
Actual Primary Completion Date September 1, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 14, 2014)
FAK expression in pediatric renal tumors [ Time Frame: Baseline ]
Original Primary Outcome Measures
 (submitted: July 15, 2012)
FAK expression in pediatric renal tumors
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Studying Biomarkers in Samples From Younger Patients With Kidney Cancer
Official Title Focal Adhesion Kinase Expression in Pediatric Renal Tumors
Brief Summary 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.
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
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Not Provided
Condition
  • Childhood Kidney Neoplasm
  • Clear Cell Renal Cell Carcinoma
  • Congenital Mesoblastic Nephroma
  • Rhabdoid Tumor of the Kidney
Intervention Other: Laboratory Biomarker Analysis
Correlative studies
Study Groups/Cohorts 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.
Intervention: Other: Laboratory Biomarker Analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: February 14, 2014)
0
Original Estimated Enrollment
 (submitted: July 15, 2012)
40
Study Completion Date Not Provided
Actual Primary Completion Date September 1, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01642095
Other Study ID Numbers AREN12B8
NCI-2012-01987 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000736805
AREN12B8
COG-AREN12B8
AREN12B8 ( Other Identifier: Childrens Oncology Group )
AREN12B8 ( Other Identifier: CTEP )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Children's Oncology Group
Study Sponsor Children's Oncology Group
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Elizabeth Beierle Children's Oncology Group
PRS Account Children's Oncology Group
Verification Date October 2017