Studying Biomarkers in Samples From Younger Patients With Wilms Tumor

Kidney Cancer Clinical Trial

Official title:

Biological Analysis of Ethnic Variations in Wilms Tumor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01542333
• Other study ID #: AREN12B2
• Secondary ID: COG-AREN12B2CDR0
• Status: Completed
• Phase: N/A
• First received: February 22, 2012
• Last updated: May 17, 2016
• Start date: February 2012

Study information

• Verified date: May 2016
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

RATIONALE: Studying samples of tissue and urine from patients with cancer in the laboratory may help doctor learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies biomarkers in samples from younger patients with Wilms tumor.

Description:

OBJECTIVES:

• To determine a unique molecular "finger print" of primary Wilms tumor arising in ethnically diverse children who are at increased risk to develop this lethal malignancy and subsequently relapse.

• To determine a unique protein "finger print" from the urine of ethnically diverse children who develop Wilms tumor and subsequent relapse.

OUTLINE: Formalin-fixed paraffin-embedded and snap-frozen primary tissue samples, and urine samples collected at the time of diagnosis and before treatment, are analyzed for molecular and protein profile by MALDI-TOF mass spectroscopy, western blotting, immunohistochemistry, and reverse-transcriptase polymerase chain reaction (RT-PCR) assays.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosed with Wilms tumor

• Specimens from African-American and from Caucasian children

• Specimens from each ethnicity who relapsed

• Specimens from each ethnicity who did NOT relapse

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• Not specified

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Kidney Cancer
• Wilms Tumor

Intervention

Genetic:
• gene expression analysis

• proteomic profiling

• reverse transcriptase-polymerase chain reaction

• western blotting

Other:
• immunohistochemistry staining method

• laboratory biomarker analysis

Procedure:
• spectroscopy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Molecular "finger print" of primary Wilms tumor in ethnically diverse children			No
Primary	Protein "finger print" from the urine of ethnically diverse children			No

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database