Studying Biomarkers in Urine Samples From Younger Patients With Wilms Tumor

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01614808
First received: June 6, 2012
Last updated: June 10, 2012
Last verified: June 2012
  Purpose

RATIONALE: Studying samples of urine from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at biomarkers in urine samples from patients with Wilms tumor.


Condition Intervention
Kidney Cancer
Other: laboratory biomarker analysis
Other: metabolic assessment
Other: specimen magnetic resonance imaging
Procedure: spectroscopy

Study Type: Observational
Official Title: Characterization of Urinary Metabolite Profiles in Wilms Tumor

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Identification of metabolomic markers in urine that would assist in identifying higher risk of relapse of Wilms tumor in otherwise lower-risk stratified patients as assessed by NMR spectroscopy and PCA [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: June 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To characterize the urinary metabolite signature of 10 stage III, favorable-histology, Wilms tumor patients from the Cooperative Human Tissue Network (CHTN) Databank, as distinct from 10 normal controls.
  • To characterize and compare the urinary metabolite profile in 50 randomly selected, stage III, favorable-histology, Wilms tumor patients enriched with an additional 30 stage III Wilms tumor patients who have relapsed.
  • To establish if the potential poor outcome (defined as relapse) in the favorable-histology group has a specific metabolite signature.
  • To characterize the urinary metabolite signature of Wilms tumor in patients with unfavorable histology (diffuse anaplasia) and compare it to those with favorable histology.

OUTLINE: Archived urine samples are analyzed for specific metabolite patterns by nuclear magnetic resonance (NMR) spectroscopy and principal component analysis (PCA). Tumor tissue may also be examined by NMR and PCA.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Patients diagnosed with stage III, favorable-histology Wilms tumors and patients diagnosed with stage III, favorable-histology Wilms tumors who have relapsed

    • Tumor samples available from both groups
  • Urine samples from the CHTN bank
  • Control urine samples
  • Urine samples from patients with unfavorable histology

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01614808

Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Dawn Maclellan, MD IWK Health Centre
  More Information

Additional Information:
No publications provided

Responsible Party: Peter C. Adamson, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01614808     History of Changes
Other Study ID Numbers: CDR0000734878, COG-AREN12B7
Study First Received: June 6, 2012
Last Updated: June 10, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent Wilms tumor and other childhood kidney tumors
stage III Wilms tumor

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

ClinicalTrials.gov processed this record on October 21, 2014