Prognostic Biomarkers in Tumor Tissue Samples From Young Patients With Neuroblastoma

Completed

• Conditions: Disseminated Neuroblastoma; Recurrent Neuroblastoma; Localized Unresectable Neuroblastoma; Stage 4S Neuroblastoma; Localized Resectable Neuroblastoma
• Interventions: Other: diagnostic laboratory biomarker analysis

• Registration Number: NCT01358617
• Lead Sponsor: Children's Oncology Group

Brief Summary

This research study is studying biomarkers in tumor tissue samples from young patients with neuroblastoma. Studying samples of tissue from patients with cancer in the laboratory may help doctors identify biomarkers and learn more about biomarkers related to cancer

Detailed Description

PRIMARY OBJECTIVES:

I. Determine whether ubiquitin carboxyl-terminal hydrolase 1 (UCHL1) expression is an indirect cancer stem cell marker in pediatric patients with neuroblastoma. Correlate UCHL1 expression with staging information and patient's outcome.

Study Subtype: Observational Observational Study Model: Case-control Time Perspective: Retrospective Biospecimen Retention: None Retained Biospecimen Description: Tissue Study Population Description: Tissue microarray samples from patients with Neuroblastoma supplied by the COG Biopathology Center Sampling Method: Probability

OUTLINE:

Archived tissue microarray samples are analyzed for ubiquitin carboxyl-terminal hydrolase 1 (UCHL1) expression by UCHL1 monoclonal antibody and peroxidase technique. Results are then compared with patients' clinical data, including age at diagnosis, race, date of diagnosis, histology, stage and location at diagnosis, presence of cancer predisposition, date of completion of treatment, surgery performed, type of chemotherapy received, history of recurrence, and status (alive with disease, alive without disease, dead), if available.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-19
• Study First Submitted QC: 2011-05-19
• Study First Posted: 2011-05-23
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-11
• Last Update Posted: 2015-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Diagnosed with neuroblastoma
• Tissue microarrays containing normal and neuroblastoma samples provided by the Children's Oncology Group (COG) Biopathology Center

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biomarker analysis	diagnostic laboratory biomarker analysis	Archived tissue microarray samples are analyzed for ubiquitin carboxyl-terminal hydrolase 1 (UCHL1) expression by UCHL1 monoclonal antibody and peroxidase technique.

Primary Outcome Measures

Name	Time	Method
Association between test result (percent cells with positive UCHL1 staining dichotomized into high and low categories) and International Neuroblastoma Staging System (INSS) stage	Baseline

Secondary Outcome Measures

Name	Time	Method
Relationship between UCHL1 expression and tumor histology, and MYCN amplification	Baseline

Trial Locations

Locations (1)

Children's Oncology Group; 🇺🇸 Monrovia, California, United States