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Biomarkers in Urine Samples From Patients With Wilms Tumor

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01550393
First Posted: March 12, 2012
Last Update Posted: July 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
  Purpose

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.


Condition Intervention
Kidney Cancer Genetic: proteomic profiling Other: enzyme-linked immunosorbent assay Other: laboratory biomarker analysis Other: medical chart review

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Discovery and Validation of Wilms Tumor Markers Using Urine Proteomics

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Wilms tumor biomarkers identified by ELISA

Biospecimen Retention:   Samples With DNA
Urine

Estimated Enrollment: 100
Study Start Date: March 2012
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 120 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with stage II-III Wilms tumors
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01550393


Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Elizabeth A. Mullen, MD Dana-Farber Cancer Institute
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01550393     History of Changes
Other Study ID Numbers: AREN12B4
COG-AREN12B4 ( Other Identifier: Children's Oncology Group )
CDR0000727337 ( Other Identifier: Clinical Trials.gov )
AREN12B4 ( Other Identifier: Children's Oncology Group )
NCI-2012-00702 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: March 6, 2012
First Posted: March 12, 2012
Last Update Posted: July 11, 2016
Last Verified: July 2016

Keywords provided by Children's Oncology Group:
stage II Wilms tumor
stage III Wilms tumor
recurrent Wilms tumor and other childhood kidney tumors

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Wilms Tumor
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Complex and Mixed
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn