Biomarkers in Tissue Samples From Patients With High-Risk Wilms Tumor
NCT ID: NCT01118078
Last Updated: 2016-05-19
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
185 participants
OBSERVATIONAL
2010-05-31
Brief Summary
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Detailed Description
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I. To assess genomic gains and losses in high risk renal tumors, including up to 80 favorable histology Wilms tumors that relapse (RFHWT), 50 anaplastic Wilms tumors (UHWT), 15 clear cell sarcomas of the kidney (CCSK), and 40 rhabdoid tumors (RT) using a high density genetic platform to survey for recurrent copy number variations and allelic imbalances. II. To define transcription patterns within 80 RFHWT, 50 UHWT, 15 CCSK, and 40 RT using a high throughput platform for global gene expression. III. To define DNA methylation patterns within 80 RFHWT, 50 UHWT, 15 CCSK, and 40 RT using a high throughput platform. IV. To identify genetic mutations involved in the pathogenesis of Wilms tumor, and in the development of relapse and anaplasia through the study of 80 RFHWT, 50 UHWT, 15 CCSK, and 40 RT using next generation sequencing tools.
V. To facilitate the integration of the above databases and allow meaningful access by investigators through the infrastructure provided by TARGET, including its data portal and associated caBIG tool.
OUTLINE: This is a multicenter study.
Archived tumor tissue samples are analyzed for DNA copy number determination, gene expression, DNA methylation, and genomic re-sequencing by array-based methods, including PCR analysis, methylation-specific reverse transcriptase-PCR (RT-PCR), and quantitative RT-PCR.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Biomarker (DNA methylation, gene expression, RT-PCR)
Archived tumor tissue samples are analyzed for DNA copy number determination, gene expression analysis, DNA methylation, and genomic re-sequencing by microarray analysis-based methods, including PCR analysis, DNA methylation analysis-specific RT-PCR, and quantitative RT-PCR (reverse transcriptase-polymerase chain reaction)
DNA methylation analysis
Undergo DNA methylation analysis
gene expression analysis
Undergo gene expression analysis
microarray analysis
Undergo microarray analysis
reverse transcriptase-polymerase chain reaction
Undergo RT-PCR
diagnostic laboratory biomarker analysis
Correlative studies
Interventions
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DNA methylation analysis
Undergo DNA methylation analysis
gene expression analysis
Undergo gene expression analysis
microarray analysis
Undergo microarray analysis
reverse transcriptase-polymerase chain reaction
Undergo RT-PCR
diagnostic laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Relapsed disease
* Anaplastic disease
* Clear cell sarcomas of the kidney
* Rhabdoid tumors
* Registered on NWTS-4, NWTS-5 (now COG-Q9401), or participation in AREN03B2 protocols with clinical follow-up \> 3 years
* Banked frozen tumor samples and paired normal DNA available with clinical data points, including the following:
* Age, race, and gender
* Stage and reason for stage
* Tumor weight
* Associated precursor lesions (rests)
* Histologic subtype
* Site and time of recurrence
* Days of follow-up
* Time and reasons for death (e.g., tumor, toxicity, infection, or other)
16 Years
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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Elizabeth Perlman, 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-2011-02230
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000672402
Identifier Type: OTHER
Identifier Source: secondary_id
COG-AREN10B2
Identifier Type: OTHER
Identifier Source: secondary_id
AREN10B2
Identifier Type: -
Identifier Source: org_study_id
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