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

Recurrent Wilms Tumor and Other Childhood Kidney Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01118078
• Other study ID #: AREN10B2
• Secondary ID: NCI-2011-02230CD
• Status: Completed
• Phase: N/A
• First received: May 5, 2010
• Last updated: May 17, 2016
• Start date: May 2010

Study information

• Verified date: May 2016
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 16 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Clear Cell Sarcoma of the Kidney
• Kidney Neoplasms
• Neoplasms
• Recurrent Wilms Tumor and Other Childhood Kidney Tumors
• Rhabdoid Tumor
• Rhabdoid Tumor of the Kidney
• Sarcoma, Clear Cell
• Stage I Wilms Tumor
• Stage II Wilms Tumor
• Stage III Wilms Tumor
• Stage IV Wilms Tumor
• Stage V Wilms Tumor
• Wilms Tumor

Intervention

Genetic:
• DNA methylation analysis
Undergo DNA methylation analysis
• gene expression analysis
Undergo gene expression analysis
• microarray analysis
Undergo microarray analysis
• reverse transcriptase-polymerase chain reaction
Undergo RT-PCR

Other:
• diagnostic laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Children's Oncology Group	Monrovia	California

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genomic gains and losses in high-risk Wilms tumor		After completion of biomarker analysis	No
Primary	Transcription patterns involved in the pathogenesis of Wilms tumor		After completion of biomarker analysis	No
Primary	Genetic mutations involved in the pathogenesis of Wilms tumor		After completion of biomarker analysis	No