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Biomarkers in Blood and Tumor Tissue Samples From Patients With Wilms Tumor

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01314391
First received: March 11, 2011
Last updated: May 17, 2016
Last verified: May 2016

March 11, 2011
May 17, 2016
August 2011
May 2016   (final data collection date for primary outcome measure)
Higher incidence of ESRD in non-syndromic WT patients with germline WT1 mutations than WT patients without WT1 mutations [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01314391 on ClinicalTrials.gov Archive Site
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Biomarkers in Blood and Tumor Tissue Samples From Patients With Wilms Tumor
Pilot Case-Control Study of WT1 Mutations in Wilms Tumor Patients Who Develop ESRD

RATIONALE: Studying samples of blood and 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 studying biomarkers in blood and tumor tissue samples from patients with Wilms tumor.

OBJECTIVES:

  • To determine whether Wilms Tumor (WT) patients without WT1-associated congenital anomalies or syndromes, but with end-stage renal disease (ESRD) unrelated to progressive bilateral tumors, carry germline WT1 mutations.
  • To determine whether non-syndromic WT1 germline mutation carriers have a substantially higher incidence of ESRD than do WT patients who do not harbor WT1 mutations.

OUTLINE: Archived blood and tumor tissue specimens (or DNA isolated from these samples) are analyzed for WT1 mutations by gene sequencing and PCR.

Observational
Observational Model: Case Control
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:
Blood and Tumor tissue
Non-Probability Sample
Diagnosis of Wilms Tumor
  • Kidney Cancer
  • Renal Failure
  • Genetic: mutation analysis
  • Genetic: polymerase chain reaction
  • Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
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May 2016   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of Wilms Tumor (WT)
  • Patients who participated in the NWTS-5 protocol

    • Non-syndromic patients who developed end-stage renal disease (ESRD) during 5-10 years for reasons other than progressive bilateral WT
    • Matched control patients who had not developed ESRD by the time (since WT onset) of ESRD diagnosis
  • Blood and tumor tissue samples available

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
Both
up to 15 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01314391
AREN11B1, COG-AREN11B1, NCI-2011-02850, AREN11B1
No
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Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Vicki Huff, PhD M.D. Anderson Cancer Center
Children's Oncology Group
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP