Studying Biomarkers in Samples From Younger Patients With Wilms Tumor

NCT ID: NCT01576198

Last Updated: 2016-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2227 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Brief Summary

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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

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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

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Kidney Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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DNA analysis

Intervention Type GENETIC

nucleic acid amplification

Intervention Type GENETIC

diagnostic laboratory biomarker analysis

Intervention Type OTHER

medical chart review

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Children's Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth J. Perlman, MD

Role: PRINCIPAL_INVESTIGATOR

Ann & Robert H Lurie Children's Hospital of Chicago

Other Identifiers

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COG-AREN11B3

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2012-00725

Identifier Type: REGISTRY

Identifier Source: secondary_id

AREN11B3

Identifier Type: OTHER

Identifier Source: secondary_id

AREN11B3

Identifier Type: -

Identifier Source: org_study_id

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