Biomarkers in Tissue Samples From Patients With High-Risk Wilms Tumor
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by National Cancer Institute (NCI).
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Children's Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01118078
First received: May 5, 2010
Last updated: May 29, 2010
Last verified: May 2010
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Purpose
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors to learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is studying biomarkers in tissue samples from patients with high-risk Wilms tumor.
| Condition | Intervention |
|---|---|
|
Kidney Cancer |
Genetic: DNA methylation analysis Genetic: gene expression analysis Genetic: microarray analysis Genetic: reverse transcriptase-polymerase chain reaction Other: laboratory biomarker analysis |
| Study Type: | Observational |
| Official Title: | Therapeutically Applicable Research to Generate Effective Treatments (TARGET) Initiative High-Risk Wilms Tumor Project: Application of Array-Based Methods and Next Generation Sequencing to Identify Candidate Molecular Targets for High-Risk Wilms Tumors |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Genomic gains and losses in high-risk Wilms tumor [ Designated as safety issue: No ]
- Transcription patterns involved in the pathogenesis of Wilms tumor [ Designated as safety issue: No ]
- Genetic mutations involved in the pathogenesis of Wilms tumor [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2010 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- To assess genomic gains and losses in samples from high-risk Wilms tumor patients, including 50 favorable histology Wilms tumors that relapse (RFHWT) and 50 anaplastic Wilms tumors (UHWT) using a high-density genetic platform to survey for recurrent copy number variations and allelic imbalances.
- To define transcription patterns within these samples using a high-throughput platform for global gene expression.
- To define DNA methylation patterns within these samples using a high-throughput platform.
- To identify genetic mutations involved in the pathogenesis of Wilms tumor and in the development of relapse and anaplasia through the study of these samples using next-generation sequencing tools.
- 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.
Eligibility| Ages Eligible for Study: | up to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Diagnosis of high-risk Wilms tumor meeting ≥ 1 of the following criteria:
- Relapsed disease
- Anaplastic disease
- Registered on NWTS-4, NWTS-5 (now COG-Q9401), or 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)
PATIENT CHARACTERISTICS:
- See Disease Characteristics
PRIOR CONCURRENT THERAPY:
- Not specified
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Gregory H. Reaman, Children's Oncology Group - Group Chair Office |
| ClinicalTrials.gov Identifier: | NCT01118078 History of Changes |
| Other Study ID Numbers: | CDR0000672402, COG-AREN10B2 |
| Study First Received: | May 5, 2010 |
| Last Updated: | May 29, 2010 |
| Health Authority: | Unspecified |
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 Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Neoplasms, Complex and Mixed Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn |
ClinicalTrials.gov processed this record on May 16, 2013