Biomarkers in Tissue Samples From Patients With High-Risk Wilms Tumor

Children's Oncology Group

Status: Completed

Conditions: Stage IV Wilms Tumor; Stage III Wilms Tumor; Stage I Wilms Tumor; Rhabdoid Tumor of the Kidney; Stage V Wilms Tumor; Stage II Wilms Tumor; Clear Cell Sarcoma of the Kidney; Recurrent Wilms Tumor and Other Childhood Kidney Tumors

Treatments: Genetic: DNA methylation analysis; Genetic: microarray analysis; Other: diagnostic laboratory biomarker analysis; Genetic: gene expression analysis; Genetic: reverse transcriptase-polymerase chain reaction

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT01118078

NCI-2011-02230 (Registry Identifier)

U10CA098543 (U.S. NIH Grant/Contract)

COG-AREN10B2 (Other Identifier)

AREN10B2

CDR0000672402 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 185 patients

Sex: All

Ages: Under 16 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

185 participants in 1 patient group

Biomarker (DNA methylation, gene expression, RT-PCR)

Description:

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)

Treatment:

Genetic: reverse transcriptase-polymerase chain reaction

Other: diagnostic laboratory biomarker analysis

Genetic: gene expression analysis

Genetic: microarray analysis

Genetic: DNA methylation analysis