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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01358617
Other study ID # ANBL11B3
Secondary ID NCI-2011-02856U1
Status Completed
Phase N/A
First received May 19, 2011
Last updated May 11, 2015
Start date May 2011
Est. completion date August 2011

Study information

Verified date May 2015
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Diagnosed with neuroblastoma

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Other:
diagnostic laboratory biomarker analysis
Correlative studies

Locations

Country Name City State
United States Children's Oncology Group Monrovia California

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Association between test result (percent cells with positive UCHL1 staining dichotomized into high and low categories) and International Neuroblastoma Staging System (INSS) stage Baseline No
Secondary Relationship between UCHL1 expression and tumor histology, and MYCN amplification Baseline No
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