Studying Biomarkers in Urine Samples From Younger Patients With Wilms Tumor
NCT ID: NCT01614808
Last Updated: 2015-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
90 participants
OBSERVATIONAL
2012-06-30
2012-06-30
Brief Summary
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Detailed Description
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I. To characterize the urinary metabolite signature of 10 stage III, favorable-histology, Wilms tumor patients from the Cooperative Human Tissue Network (CHTN) Databank, as distinct from 10 normal controls.
II. To characterize and compare the urinary metabolite profile in 50 randomly selected, stage III, favorable-histology, Wilms tumor patients enriched with an additional 30 stage III Wilms tumor patients who have relapsed.
III. To establish if the potential poor outcome (defined as relapse) in the favorable-histology group has a specific metabolite signature.
IV. To characterize the urinary metabolite signature of Wilms tumor in patients with unfavorable histology (diffuse anaplasia) and compare it to those with favorable histology.
OUTLINE:
Archived urine samples are analyzed for specific metabolite patterns by nuclear magnetic resonance (NMR) spectroscopy and principal component analysis (PCA). Tumor tissue may also be examined by NMR and PCA.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Observational
Archived urine samples are analyzed for specific metabolite patterns by nuclear magnetic resonance (NMR) spectroscopy and principal component analysis (PCA). Tumor tissue may also be examined by NMR and PCA.
laboratory biomarker analysis
Correlative studies
Interventions
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laboratory biomarker analysis
Correlative studies
Eligibility Criteria
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Inclusion Criteria
* Tumor samples available from both groups
* Urine samples from the CHTN bank
* Control urine samples
* Urine samples from patients with unfavorable histology
* Not specified
* Not specified
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Dawn Maclellan, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Oncology Group
Locations
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Children's Oncology Group
Monrovia, California, United States
Countries
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Other Identifiers
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NCI-2012-01973
Identifier Type: REGISTRY
Identifier Source: secondary_id
AREN12B7
Identifier Type: -
Identifier Source: org_study_id
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