NCT01576198

Studying Biomarkers in Samples From Younger Patients With Wilms Tumor

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,227 (estimated)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Kidney Cancer

Interventions

Type	Name	Description
GENETIC	DNA analysis
GENETIC	nucleic acid amplification
OTHER	diagnostic laboratory biomarker analysis
OTHER	medical chart review

Timeline

• Start date: 2012-04-01
• Primary completion: 2016-07-01
• First posted: 2012-04-12
• Last updated: 2016-07-14