NeuroblastomaNCT01520233
Gene Expression in Predicting Outcome in Samples From Patients With High-Risk Neuroblastoma
An observational study of Neuroblastoma, run by Children's Oncology Group.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neuroblastoma
- What is being tested?
- RNA analysis, gene expression analysis and laboratory biomarker analysis
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
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
About this study
Official title: Genome Based Outcome Prediction in High Risk Neuroblastoma
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.
- Conditions
- Neuroblastoma
- Being tested
- RNA analysis, gene expression analysis, laboratory biomarker analysis
- Keywords
- disseminated neuroblastoma, localized unresectable neuroblastoma, recurrent neuroblastoma, regional neuroblastoma, stage 4S neuroblastoma
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RNA analysisGenetic
gene expression analysisGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear correlation between the nCounter™ Analysis System and the expression data obtained in microarray platforms
nCounter™ Analysis System and microarray platforms equally predictive of outcome in the high-risk group of neuroblastoma patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroblastomaStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Susan L. Cohn, MD, Principal investigator, University of Chicago Comer Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520233
- Sponsor's protocol ID
- ANBL12B2
- Other IDs
- COG-ANBL12B2, CDR0000723895, ANBL12B2, NCI-2012-00240
- Status last verified
- May 2016
- First submitted
- 26 Jan 2012
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genome Based Outcome Prediction in High Risk Neuroblastoma
- ClinicalTrials.gov ID
- NCT01520233
- Acronym / sponsor ID
- ANBL12B2
- Conditions
- Neuroblastoma
- Keywords
- disseminated neuroblastoma, localized unresectable neuroblastoma, recurrent neuroblastoma, regional neuroblastoma, stage 4S neuroblastoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2012
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 27 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RNA analysis | Genetic | – |
| gene expression analysis | Genetic | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Linear correlation between the nCounter™ Analysis System and the expression data obtained in microarray platforms
nCounter™ Analysis System and microarray platforms equally predictive of outcome in the high-risk group of neuroblastoma patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan L. Cohn, MD principal investigator
University of Chicago Comer Children's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroblastoma, run by Children's Oncology Group.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linear correlation between the nCounter™ Analysis System and the expression data obtained in microarray platforms. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2016.