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Validation of Copy Number Changes by MLPA as Predictors of Relapse in Wilms Tumor


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Open (Enrolling)
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Kidney Cancer

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Trial Information

Validation of Copy Number Changes by MLPA as Predictors of Relapse in Wilms Tumor


OBJECTIVES:

- To analyze 250 favorable-histology Wilms tumor (FHWT) samples from patients registered
on NWTS4 for gain of 1q and 15q, and loss of 1p, 16q, 17p, and 22q by subtelomeric
multiplex ligation-dependent probe amplification (MLPA), and to determine their
association with relapse-free and overall survival.

- To develop a robust multiplex MLPA test using multiple synthesized probes to those
targets identified as significantly associated with relapse in Aim 1.

- To validate the multiplex MLPA test designed and tested in Aim 2 on an independent set
of 1727 FHWT and 250 anaplastic WT registered on NWTS-5.

OUTLINE: Archived DNA samples are analyzed for gain of 1q and 15q, and loss of 1p, 16q, 17p,
and 22q by MLPA. Assay results are then researched for accuracy, clinical validity,
sensitivity, precision, and potential analytical interferences.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- DNA samples from FHWT patients registered on:

- NWTS-4

- NWTS-5 with focal and diffuse anaplasia tumors

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- Not specified

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Validation of copy number changes (gain of 1q and 15q, and loss of 1p, 16q, 17p, and 22q) in FHWT by the MLPA assay

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:

United States: Federal Government

Study ID:

CDR0000730403

NCT ID:

NCT01576198

Start Date:

April 2012

Completion Date:

Related Keywords:

  • Kidney Cancer
  • Wilms tumor and other childhood kidney tumors
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Wilms Tumor

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