Biomarkers in Tissue Samples From Patients With High-Risk Wilms Tumor
|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.|
|ClinicalTrials.gov Identifier: NCT01118078|
Recruitment Status : Completed
First Posted : May 6, 2010
Last Update Posted : May 19, 2016
|Condition or disease||Intervention/treatment|
|Clear Cell Sarcoma of the Kidney Recurrent Wilms Tumor and Other Childhood Kidney Tumors Rhabdoid Tumor of the Kidney Stage I Wilms Tumor Stage II Wilms Tumor Stage III Wilms Tumor Stage IV Wilms Tumor Stage V Wilms Tumor||Genetic: DNA methylation analysis Genetic: gene expression analysis Genetic: microarray analysis Genetic: reverse transcriptase-polymerase chain reaction Other: diagnostic laboratory biomarker analysis|
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.
|Study Type :||Observational|
|Actual Enrollment :||185 participants|
|Official Title:||Therapeutically Applicable Research to Generate Effective Treatments (TARGET) Initiative High-Risk Renal Tumor Project: Application of Array-Based Methods and Next Generation Sequencing to Identify Candidate Molecular Targets for High-Risk Wilms Tumors|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||May 2016|
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)
Genetic: DNA methylation analysis
Undergo DNA methylation analysisGenetic: gene expression analysis
Undergo gene expression analysisGenetic: microarray analysis
Undergo microarray analysis
Other Name: gene expression profilingGenetic: reverse transcriptase-polymerase chain reaction
Other Name: RT-PCROther: diagnostic laboratory biomarker analysis
- Genomic gains and losses in high-risk Wilms tumor [ Time Frame: After completion of biomarker analysis ]
- Transcription patterns involved in the pathogenesis of Wilms tumor [ Time Frame: After completion of biomarker analysis ]
- Genetic mutations involved in the pathogenesis of Wilms tumor [ Time Frame: After completion of biomarker analysis ]
Biospecimen Retention: Samples With DNA
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): NCT01118078
|United States, California|
|Children's Oncology Group|
|Monrovia, California, United States, 91006-3776|
|Principal Investigator:||Elizabeth Perlman, MD||Children's Oncology Group|