- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01118078
Biomarkers in Tissue Samples From Patients With High-Risk Wilms Tumor
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 Overview
Status
Conditions
Detailed Description
OBJECTIVES:
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Monrovia, California, United States, 91006-3776
- Children's Oncology Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Diagnosis of high-risk Wilms tumor meeting ≥ 1 of the following 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)
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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)
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Correlative studies
Undergo DNA methylation analysis
Undergo gene expression analysis
Undergo microarray analysis
Other Names:
Undergo RT-PCR
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Genomic gains and losses in high-risk Wilms tumor
Time Frame: After completion of biomarker analysis
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After completion of biomarker analysis
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Transcription patterns involved in the pathogenesis of Wilms tumor
Time Frame: After completion of biomarker analysis
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After completion of biomarker analysis
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Genetic mutations involved in the pathogenesis of Wilms tumor
Time Frame: After completion of biomarker analysis
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After completion of biomarker analysis
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Genetic Diseases, Inborn
- Neoplastic Syndromes, Hereditary
- Neoplasms, Complex and Mixed
- Neoplasms, Connective Tissue
- Sarcoma
- Neoplasms
- Kidney Neoplasms
- Rhabdoid Tumor
- Wilms Tumor
- Sarcoma, Clear Cell
Other Study ID Numbers
- AREN10B2
- U10CA098543 (U.S. NIH Grant/Contract)
- NCI-2011-02230 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- CDR0000672402 (Other Identifier: Clinical Trials.gov)
- COG-AREN10B2 (Other Identifier: Children's Oncology Group)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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