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CompletedNCT01520233Updated May 17, 2016

Gene Expression in Predicting Outcome in Samples From Patients With High-Risk Neuroblastoma

An observational study in Neuroblastoma, sponsored by Children's Oncology Group. Completed. Per ClinicalTrials.gov, last updated 2016-05-17.

Sponsored by Children's Oncology Group · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
Sex
All
01

Study summary

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in RNA and predict how patients will respond to treatment. It may also help doctors find better ways to treat cancer.

PURPOSE: This research trial studies gene expression in predicting outcomes in samples from patients with high-risk neuroblastoma.

Read the detailed description

OBJECTIVES:

  • To test the correlation of a previously published microarray gene expression signature with the gene expression obtained with the nCounter™ Analysis System using RNA isolated from formalin-fixed, paraffin-embedded (FFPE), high-risk neuroblastoma samples.
  • To construct, test, and validate a novel robust classifier that can be readily integrated into the clinic.

OUTLINE: This is a multicenter study.

RNA samples extracted from paraffin-embedded tissue are analyzed for gene signature expression levels by nCounter™ Analysis System and correlated with published microarray expression data. Results are then used to develop a refined gene-expression-profile classifier of ultra high-risk neuroblastoma.

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Conditions studied

  • Neuroblastoma

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Keywords

  • disseminated neuroblastoma
  • localized unresectable neuroblastoma
  • recurrent neuroblastoma
  • regional neuroblastoma
  • stage 4S neuroblastoma
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In context

Neuroblastoma

634 studies on the registry are indexed under Neuroblastoma; 122 are open to participants now.

This study's enrollment of 100 is below the median of 121 across 79 observational studies indexed under Neuroblastoma.

Browse Neuroblastoma studies →

Lead sponsor

Children's Oncology Group is the lead sponsor of 447 studies on the registry; 35 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Neuroblastoma patients treated at the University of Chicago, St. Jude Children's Research Hospital, Children's Memorial Hospital, or Texas Children's Hospital.

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Formalin-fixed paraffin-embedded tumor sections linked to clinical and outcome data collected from high-risk neuroblastoma patients (n=100) treated at the University of Chicago, St. Jude Children's Research Hospital, Children's Memorial Hospital, or Texas Children's Hospital

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100 participants (actual)
Patient registry
No

Interventions

  • GeneticRNA analysis
  • Geneticgene expression analysis
  • Otherlaboratory biomarker analysis
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What researchers measure

Primary outcomes

  1. Linear correlation between the nCounter™ Analysis System and the expression data obtained in microarray platforms

  2. nCounter™ Analysis System and microarray platforms equally predictive of outcome in the high-risk group of neuroblastoma patients

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2012, a primary completion of May 2016 and a completion of May 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 26, 2012
First posted
Jan 27, 2012
Start
Jan 2012
Primary completionActual
May 2016
CompletionActual
May 2016
Last update
May 17, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01520233
Lead sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 27, 2012
Start date
Jan 2012
Primary completion
May 2016
Completion
May 2016
Last update
May 17, 2016

Study contacts

Susan L. Cohn, MD
principal investigator · University of Chicago Comer Children's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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