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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01314391
First Posted: March 14, 2011
Last Update Posted: May 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
  Purpose

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.


Condition Intervention
Kidney Cancer Renal Failure Genetic: mutation analysis Genetic: polymerase chain reaction Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Pilot Case-Control Study of WT1 Mutations in Wilms Tumor Patients Who Develop ESRD

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Higher incidence of ESRD in non-syndromic WT patients with germline WT1 mutations than WT patients without WT1 mutations

Biospecimen Retention:   Samples With DNA
Blood and Tumor tissue

Estimated Enrollment: 20
Study Start Date: August 2011
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diagnosis of Wilms Tumor
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01314391


Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Vicki Huff, PhD M.D. Anderson Cancer Center
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01314391     History of Changes
Other Study ID Numbers: AREN11B1
COG-AREN11B1 ( Other Identifier: Children's Oncology Group )
NCI-2011-02850 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
AREN11B1 ( Other Identifier: Children's Oncology Group )
First Submitted: March 11, 2011
First Posted: March 14, 2011
Last Update Posted: May 18, 2016
Last Verified: May 2016

Keywords provided by Children's Oncology Group:
stage I Wilms tumor
stage II Wilms tumor
stage III Wilms tumor
stage IV Wilms tumor
stage V Wilms tumor
renal failure

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Neoplasms
Carcinoma, Renal Cell
Wilms Tumor
Kidney Diseases
Urologic Diseases
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Complex and Mixed
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn