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Therapeutically Applicable Research to Generate Effective Treatments (TARGET) Initiative High-Risk Wilms Tumor Project: Application of Array-Based Methods and Next Generation Sequencing to Identify Candidate Molecular Targets for High-Risk Wilms Tumors


N/A
N/A
16 Years
Not Enrolling
Both
Kidney Cancer

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Trial Information

Therapeutically Applicable Research to Generate Effective Treatments (TARGET) Initiative High-Risk Wilms Tumor Project: Application of Array-Based Methods and Next Generation Sequencing to Identify Candidate Molecular Targets for High-Risk Wilms Tumors


OBJECTIVES:

- To assess genomic gains and losses in samples from high-risk Wilms tumor patients,
including 50 favorable histology Wilms tumors that relapse (RFHWT) and 50 anaplastic
Wilms tumors (UHWT) using a high-density genetic platform to survey for recurrent copy
number variations and allelic imbalances.

- To define transcription patterns within these samples using a high-throughput platform
for global gene expression.

- To define DNA methylation patterns within these samples using a high-throughput
platform.

- To identify genetic mutations involved in the pathogenesis of Wilms tumor and in the
development of relapse and anaplasia through the study of these samples using
next-generation sequencing tools.

- 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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of high-risk Wilms tumor meeting ≥ 1 of the following criteria:

- Relapsed disease

- Anaplastic disease

- Registered on NWTS-4, NWTS-5 (now COG-Q9401), or 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)

PATIENT CHARACTERISTICS:

- See Disease Characteristics

PRIOR CONCURRENT THERAPY:

- Not specified

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Genomic gains and losses in high-risk Wilms tumor

Safety Issue:

No

Principal Investigator

Elizabeth J. Perlman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ann & Robert H Lurie Children's Hospital of Chicago

Authority:

Unspecified

Study ID:

CDR0000672402

NCT ID:

NCT01118078

Start Date:

March 2010

Completion Date:

Related Keywords:

  • Kidney Cancer
  • recurrent Wilms tumor and other childhood kidney tumors
  • stage I Wilms tumor
  • stage II Wilms tumor
  • stage III Wilms tumor
  • stage IV Wilms tumor
  • stage V Wilms tumor
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Wilms Tumor

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