NCT01358604

Brief Summary

RATIONALE: Studying samples of tissue and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study studies biomarkers in samples from young patients with neuroblastoma.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2011

Longer than P75 for all trials

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
17 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 23, 2011

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 15, 2016

Status Verified

April 1, 2016

Enrollment Period

4.9 years

First QC Date

May 18, 2011

Last Update Submit

April 14, 2016

Conditions

Keywords

localized resectable neuroblastomarecurrent neuroblastomaregional neuroblastomastage 4S neuroblastomalocalized unresectable neuroblastoma

Outcome Measures

Primary Outcomes (1)

  • ROR1 is expressed on the surface of neuroblastoma cells and constitutes a suitable target for mAb therapy

Interventions

Eligibility Criteria

AgeUp to 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with neuroblastoma.

DISEASE CHARACTERISTICS: * Diagnosed with neuroblastoma * With or without N-myc amplification * Primary tumor samples as frozen tissue in liquid nitrogen or -80 degrees C * Bone marrow samples from high-risk patients as peripheral blood mononuclear cells (PBMC) that have been cryopreserved with DMSO as viable cells to be used for flow cytometry or slides of bone marrow that can be used for immunohistochemistry PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Neuroblastoma

Interventions

Polymerase Chain ReactionBlotting, WesternFlow CytometryImmunohistochemistry

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nucleic Acid Amplification TechniquesGenetic TechniquesInvestigative TechniquesElectrophoresisChemistry Techniques, AnalyticalElectrochemical TechniquesImmunoblottingImmunoassayImmunologic TechniquesMolecular Probe TechniquesCell SeparationCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisCytophotometryFluorometryLuminescent MeasurementsPhotometryHistocytochemistryHistological Techniques

Study Officials

  • David Hema, MD, MPH

    NCI - Experimental Transplantation and Immunology Branch

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 18, 2011

First Posted

May 23, 2011

Study Start

May 1, 2011

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 15, 2016

Record last verified: 2016-04