Prognostic Biomarkers in Tumor Tissue Samples From Young Patients With Neuroblastoma

• Sponsor: Children's Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT01358617
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 90
• Location: 1
• Duration (Months): 3
• Patients Per Site Per Month: 29.8

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Disseminated Neuroblastoma; Localized Resectable Neuroblastoma; Localized Unresectable Neuroblastoma; Recurrent Neuroblastoma; Stage 4S Neuroblastoma	Other: diagnostic laboratory biomarker analysis

Detailed Description

PRIMARY OBJECTIVES:

1. 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 Design

• Study Type: Observational
• Actual Enrollment: 90 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Observational - Expression of Ubiquitin Carboxyl-Terminal Hydrolase 1 (UCHL1) in Neuroblastoma Cancer Stem Cells and Its Relationship to Patient Prognosis
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Biomarker analysis Archived tissue microarray samples are analyzed for ubiquitin carboxyl-terminal hydrolase 1 (UCHL1) expression by UCHL1 monoclonal antibody and peroxidase technique.	Other: diagnostic laboratory biomarker analysis; Correlative studies

Outcome Measures

Primary Outcome Measures

1. 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

1. Relationship between UCHL1 expression and tumor histology, and MYCN amplification [Baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosed with neuroblastoma

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Oncology Group	Monrovia	California	United States	91006-3776

Sponsors and Collaborators

• Children's Oncology Group
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Aaron Sugalski, MD, Children's Oncology Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Children's Oncology Group
• ClinicalTrials.gov Identifier: NCT01358617
• Other Study ID Numbers: ANBL11B3; NCI-2011-02856; U10CA098543
• First Posted: May 23, 2011
• Last Update Posted: May 12, 2015
• Last Verified: May 1, 2015

• Additional relevant MeSH terms: Neuroblastoma

Study Results

No Results Posted as of May 12, 2015