Biomarkers in Tissue Samples From Patients With High-Risk Wilms Tumor
Conditions
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
Conditions: official terms
Kidney Neoplasms - Neoplasms - Rhabdoid Tumor - Sarcoma, Clear Cell - Wilms Tumor
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case-Only, Time Perspective: Prospective
Intervention
Name: DNA methylation analysis Type: Genetic
Name: gene expression analysis Type: Genetic
Name: microarray analysis Type: Genetic
Name: reverse transcriptase-polymerase chain reaction Type: Genetic
Name: diagnostic laboratory biomarker analysis Type: Other
Overall Status
Recruiting
Summary
This research study is studying biomarkers in tissue samples from patients with high-risk Wilms tumor. 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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 16 Years
Minimum Age: N/A
Gender: Both
Criteria: 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)
Location
Children's Oncology Group
Monrovia, California, United States
Status: Recruiting
Contact: Elizabeth J. Perlman, MD - 773-880-4306 - eperlman@childrensmemorial.org
Start Date
May 2010
Sponsors
Children's Oncology Group
Source
Children's Oncology Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page