NCT01553448

Brief Summary

RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer. PURPOSE: This research trial studies gene expression in samples from younger patients with neuroblastoma.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 14, 2012

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

May 18, 2016

Status Verified

May 1, 2016

Enrollment Period

4.2 years

First QC Date

March 13, 2012

Last Update Submit

May 17, 2016

Conditions

Keywords

disseminated neuroblastomahereditary neuroblastomalocalized resectable neuroblastomalocalized unresectable neuroblastomastage 4S neuroblastoma

Outcome Measures

Primary Outcomes (2)

  • Expression of TβRIII in the neuroblastic tumor and stroma of patients with advanced-stage NBL

  • Correlation between TβRIII levels and TGF-β signaling correlate with NBL stage, tumor stroma content, surface TβRIII expression, and TGF-β signaling

Interventions

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with low-stage (International Neuroblastoma Staging System \[INSS\] stage 1 or 2) neuroblastoma (NBL), patients with advanced-stage (INSS stage 3 or 4) NBL, or patients with stage 4S NBL

DISEASE CHARACTERISTICS: * Tissue samples and matched plasma samples available from 1 of the following groups: * Patients with low-stage (International Neuroblastoma Staging System \[INSS\] stage 1 or 2) neuroblastoma (NBL) * Patients with advanced-stage (INSS stage 3 or 4) NBL * Patients with stage 4S NBL * Clinical and/or outcome data associated with the tissue and plasma samples including INSS stage, age, MYCN amplification status, chromosomal alterations, and 5-year survival, if known 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

NeoplasmsNeuroblastoma

Interventions

Gene Expression ProfilingEnzyme-Linked Immunosorbent AssayImmunohistochemistry

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative TechniquesImmunoenzyme TechniquesImmunoassayImmunologic TechniquesImmunosorbent TechniquesMolecular Probe TechniquesHistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological Techniques

Study Officials

  • Gerard C. Blobe, MD, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 13, 2012

First Posted

March 14, 2012

Study Start

March 1, 2012

Primary Completion

May 1, 2016

Last Updated

May 18, 2016

Record last verified: 2016-05