Studying Biomarkers in Samples From Younger Patients With Wilms Tumor
RATIONALE: Studying samples of blood, tissue, or bone marrow 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.
PURPOSE: This research trial studies biomarkers in samples from younger patients with Wilms tumor.
Genetic: DNA analysis
Genetic: nucleic acid amplification
Other: diagnostic laboratory biomarker analysis
Other: medical chart review
|Study Design:||Observational Model: Case-Only
Time Perspective: Retrospective
|Official Title:||Validation of Copy Number Changes by MLPA as Predictors of Relapse in Wilms Tumor|
- Validation of copy number changes (gain of 1q and 15q, and loss of 1p, 16q, 17p, and 22q) in FHWT by the MLPA assay [ Designated as safety issue: No ]
|Study Start Date:||April 2012|
|Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01576198
|Principal Investigator:||Elizabeth J. Perlman, MD||Ann & Robert H Lurie Children's Hospital of Chicago|