Trial record 3 of 164 for:    "Wilms tumor"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01118078
First received: May 5, 2010
Last updated: July 8, 2013
Last verified: July 2013
  Purpose

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.


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

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Genomic gains and losses in high-risk Wilms tumor [ Time Frame: After completion of biomarker analysis ] [ Designated as safety issue: No ]
  • Transcription patterns involved in the pathogenesis of Wilms tumor [ Time Frame: After completion of biomarker analysis ] [ Designated as safety issue: No ]
  • Genetic mutations involved in the pathogenesis of Wilms tumor [ Time Frame: After completion of biomarker analysis ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Archived tumor tissue samples


Estimated Enrollment: 185
Study Start Date: May 2010
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Biomarker (DNA methylation, gene expression, RT-PCR)
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)
Genetic: DNA methylation analysis
Undergo DNA methylation analysis
Genetic: gene expression analysis
Undergo gene expression analysis
Genetic: microarray analysis
Undergo microarray analysis
Other Name: gene expression profiling
Genetic: reverse transcriptase-polymerase chain reaction
Undergo RT-PCR
Other Name: RT-PCR
Other: diagnostic laboratory biomarker analysis
Correlative studies

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

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01118078

Locations
United States, California
Children's Oncology Group Recruiting
Arcadia, California, United States, 91006-3776
Contact: Elizabeth J. Perlman    773-880-4306    eperlman@childrensmemorial.org   
Principal Investigator: Elizabeth J. Perlman         
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Elizabeth Perlman Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01118078     History of Changes
Other Study ID Numbers: AREN10B2, NCI-2011-02230, CDR0000672402, U10CA098543, COG-AREN10B2
Study First Received: May 5, 2010
Last Updated: July 8, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Wilms Tumor
Kidney Neoplasms
Sarcoma, Clear Cell
Rhabdoid Tumor
Sarcoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue

ClinicalTrials.gov processed this record on July 29, 2014