Biomarkers in Urine Samples From Patients With Wilms Tumor

NCT ID: NCT01550393

Last Updated: 2016-07-11

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

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Brief Summary

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RATIONALE: Studying samples of urine from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer.

PURPOSE: This clinical trial studies biomarkers in urine from patients with Wilms tumor.

Detailed Description

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OBJECTIVES:

* To validate the prognostic performance of specific-candidate Wilms tumor markers by measuring their urinary concentration using enzyme-linked immunosorbent assays (ELISAs) in urine specimens collected at diagnosis from 50 patients with favorable histology Wilms tumor who relapsed and 50 patients who did not relapse.

OUTLINE: Urine specimens are analyzed using enzyme-linked immunosorbent assays (ELISAs) for biomarkers.

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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proteomic profiling

Intervention Type GENETIC

enzyme-linked immunosorbent assay

Intervention Type OTHER

laboratory biomarker analysis

Intervention Type OTHER

medical chart review

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Urine specimens collected at diagnosis will be selected from patients with stage II-III Wilms tumors, with both local and non-local sites of disease relapse
* Clinical patient information (urinalysis/macro, age, gender, congenital defects/syndromes, comorbidities, tumor stage, size, pathology, therapy, outcome) available

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 A. Mullen, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Other Identifiers

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COG-AREN12B4

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000727337

Identifier Type: OTHER

Identifier Source: secondary_id

AREN12B4

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2012-00702

Identifier Type: REGISTRY

Identifier Source: secondary_id

AREN12B4

Identifier Type: -

Identifier Source: org_study_id

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