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Studying Biomarkers in Samples From Younger Patients With Wilms Tumor

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01542333
First received: February 22, 2012
Last updated: February 25, 2012
Last verified: February 2012
  Purpose

RATIONALE: Studying samples of tissue and urine from patients with cancer in the laboratory may help doctor learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies biomarkers in samples from younger patients with Wilms tumor.


Condition Intervention
Kidney Cancer
Genetic: gene expression analysis
Genetic: proteomic profiling
Genetic: reverse transcriptase-polymerase chain reaction
Genetic: western blotting
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Procedure: spectroscopy

Study Type: Observational
Official Title: Biological Analysis of Ethnic Variations in Wilms Tumor

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Molecular "finger print" of primary Wilms tumor in ethnically diverse children [ Designated as safety issue: No ]
  • Protein "finger print" from the urine of ethnically diverse children [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: February 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To determine a unique molecular "finger print" of primary Wilms tumor arising in ethnically diverse children who are at increased risk to develop this lethal malignancy and subsequently relapse.
  • To determine a unique protein "finger print" from the urine of ethnically diverse children who develop Wilms tumor and subsequent relapse.

OUTLINE: Formalin-fixed paraffin-embedded and snap-frozen primary tissue samples, and urine samples collected at the time of diagnosis and before treatment, are analyzed for molecular and protein profile by MALDI-TOF mass spectroscopy, western blotting, immunohistochemistry, and reverse-transcriptase polymerase chain reaction (RT-PCR) assays.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosed with Wilms tumor
  • Specimens from African-American and from Caucasian children
  • Specimens from each ethnicity who relapsed
  • Specimens from each ethnicity who did NOT relapse

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01542333

Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Harold N. Lovvorn, III, MD Vanderbilt Children's Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Peter C. Adamson, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01542333     History of Changes
Other Study ID Numbers: CDR0000726713, COG-AREN12B2
Study First Received: February 22, 2012
Last Updated: February 25, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent Wilms tumor and other childhood kidney tumors
stage I Wilms tumor
stage II Wilms tumor
stage III Wilms tumor
stage IV Wilms tumor
stage V Wilms tumor

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

ClinicalTrials.gov processed this record on November 19, 2014