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Prognostic Biomarkers in Tumor Tissue Samples From Young Patients With Neuroblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01358617
Recruitment Status : Completed
First Posted : May 23, 2011
Last Update Posted : May 12, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Disseminated Neuroblastoma Localized Resectable Neuroblastoma Localized Unresectable Neuroblastoma Recurrent Neuroblastoma Stage 4S Neuroblastoma Other: diagnostic laboratory biomarker analysis

Detailed Description:


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


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 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 2011
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma
U.S. FDA Resources

Group/Cohort 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

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 [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Relationship between UCHL1 expression and tumor histology, and MYCN amplification [ Time Frame: Baseline ]

Biospecimen Retention:   Samples With DNA
Tumor Tissue

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients With Neuroblastoma

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01358617

United States, California
Children's Oncology Group
Monrovia, California, United States, 91006-3776
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Aaron Sugalski, MD Children's Oncology Group

Responsible Party: Children's Oncology Group Identifier: NCT01358617     History of Changes
Other Study ID Numbers: ANBL11B3
NCI-2011-02856 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
U10CA098543 ( U.S. NIH Grant/Contract )
First Posted: May 23, 2011    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue