NCT01358617

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 23, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

May 12, 2015

Status Verified

May 1, 2015

Enrollment Period

3 months

First QC Date

May 19, 2011

Last Update Submit

May 11, 2015

Conditions

Disseminated NeuroblastomaLocalized Resectable NeuroblastomaLocalized Unresectable NeuroblastomaRecurrent NeuroblastomaStage 4S Neuroblastoma

Outcome Measures

Primary Outcomes (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 Outcomes (1)

  • Relationship between UCHL1 expression and tumor histology, and MYCN amplification

    Baseline

Study Arms (1)

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

Interventions

diagnostic laboratory biomarker analysisOTHER

Correlative studies

Biomarker analysis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients With Neuroblastoma

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Oncology Group

Monrovia, California, 91006-3776, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumor Tissue

MeSH Terms

Conditions

Neuroblastoma

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Aaron Sugalski, MD

    Children's Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2011

First Posted

May 23, 2011

Study Start

May 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

May 12, 2015

Record last verified: 2015-05

Locations

US(1)