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CompletedNCT01550393Updated Jul 11, 2016

Biomarkers in Urine Samples From Patients With Wilms Tumor

An observational study in Kidney Cancer, sponsored by Children's Oncology Group. Completed. Open to participants aged Up to 120 Years. Per ClinicalTrials.gov, last updated 2016-07-11.

Sponsored by Children's Oncology Group · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
100
Ages
Up to 120 Years
Sex
All
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Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Kidney Cancer

Keywords

  • stage II Wilms tumor
  • stage III Wilms tumor
  • recurrent Wilms tumor and other childhood kidney tumors
03

In context

Kidney Neoplasms

956 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.

This study's planned enrollment of 100 is below the median of 218 across 216 observational studies indexed under Kidney Neoplasms.

Browse Kidney Neoplasms studies →

Lead sponsor

Children's Oncology Group is the lead sponsor of 436 studies on the registry; 34 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with stage II-III Wilms tumors

Eligibility 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
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • Geneticproteomic profiling
  • Otherenzyme-linked immunosorbent assay
  • Otherlaboratory biomarker analysis
  • Othermedical chart review
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What researchers measure

Primary outcomes

  1. Wilms tumor biomarkers identified by ELISA

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Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01550393
Lead sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Mar 12, 2012
Start date
Mar 2012
Primary completion
Jul 2016
Last update
Jul 11, 2016

Study contacts

Elizabeth A. Mullen, MD
principal investigator · Dana-Farber Cancer Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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