Studying Biomarkers in Urine Samples From Younger Patients With Wilms Tumor

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01614808
First received: June 6, 2012
Last updated: May 6, 2015
Last verified: May 2015
  Purpose

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


Condition Intervention
Recurrent Wilms Tumor and Other Childhood Kidney Tumors
Stage III Wilms Tumor
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Observational - Characterization of Urinary Metabolite Profiles in Wilms Tumor

Resource links provided by NLM:


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

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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Urine


Enrollment: 90
Study Start Date: June 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Observational
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.
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. 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.

II. 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.

III. To establish if the potential poor outcome (defined as relapse) in the favorable-histology group has a specific metabolite signature.

IV. 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
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • 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
  • Not specified
  • 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

Locations
United States, California
Children's Oncology Group
Monrovia, California, United States, 91006-3776
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Dawn Maclellan, MD Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01614808     History of Changes
Other Study ID Numbers: AREN12B7, NCI-2012-01973
Study First Received: June 6, 2012
Last Updated: May 6, 2015
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 29, 2015