Clinical trial NCT01118078: Biomarkers in Tissue Samples From Patients With High-Risk Wilms Tumor
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 type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-05-06
Enrollment: 185
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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)

Brief 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.

Eligibility 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)

Primary outcomes:
measure: Genomic gains and losses in high-risk Wilms tumor
timeFrame: After completion of biomarker analysis
measure: Transcription patterns involved in the pathogenesis of Wilms tumor
timeFrame: After completion of biomarker analysis
measure: Genetic mutations involved in the pathogenesis of Wilms tumor
timeFrame: After completion of biomarker analysis
Secondary outcomes:
Other outcomes:
Locations:
city: Monrovia
country: United States
facility: Children's Oncology Group
state: California
Study officials:
affiliation: Children's Oncology Group
name: Elizabeth Perlman, MD
role: PRINCIPAL_INVESTIGATOR
References: