NeuroblastomaNCT01493830
Biomarkers in Tumor Samples From Younger Patients With 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 DNA and identify biomarkers related to cancer. PURPOSE: This research trial studies biomarkers in tumor samples from younger patients with neuroblastoma. Read more about this study
- Who is it for?
- Ages Up to 120 years
- Conditions the study is for
- Neuroblastoma
- What is being tested?
- fluorescence in situ hybridization, gene expression analysis and microarray analysis
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to Jul 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 Up to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients With Neuroblastoma
DISEASE CHARACTERISTICS:
- Tumor tissue microarrays from the Children's Oncology Group neuroblastoma tumor bank
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Proposed Studies on the Role of Growth Factor Receptor Trafficking in Neuroblastoma Pathogenesis
RATIONALE: Studying samples of 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.
PURPOSE: This research trial studies biomarkers in tumor samples from younger patients with neuroblastoma.
Read the detailed description
OBJECTIVES:
- To determine the expression of UBE4B, hrs, and members of the ubiquitination protein complex in previously banked primary neuroblastoma tumor samples from the Children's Oncology Group.
- To determine the correlation of expression levels and cellular localization of the UBE4B and hrs proteins with growth factor-receptor tumor cell-surface expression.
- To determine the 1p36 deletion status by fluorescence in situ hybridization (FISH) analysis and their association with expression levels of UBE4B and hrs in previously banked primary neuroblastoma tumor samples from the Children's Oncology Group.
OUTLINE: Banked tumor tissue samples are analyzed for expression of UBE4B, hrs, members of the ubiquitination protein complex, growth factor receptors, and 1p36 deletion status by immunohistochemistry (IHC), fluorescent microscopy, and fluorescence in situ hybridization (FISH).
- Conditions
- Neuroblastoma
- Being tested
- fluorescence in situ hybridization, gene expression analysis, microarray analysis, mutation analysis, protein analysis
- Keywords
- neuroblastoma
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorescence in situ hybridizationGenetic
gene expression analysisGenetic
microarray analysisGenetic
mutation analysisGenetic
protein analysisGenetic
laboratory biomarker analysisOther
microscopyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of UBE4B, hrs, and members of the ubiquitination protein complex
Expression levels and cellular localization of the UBE4B, hrs, and growth factor receptors
1p36 deletion status and its association with UBE4B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionJul 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Peter Zage, MD, PhD, Principal investigator, Texas Children's Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493830
- Sponsor's protocol ID
- ANBL12B4
- Other IDs
- COG-ANBL12B4, NCI-2012-00091, ANBL12B4
- Status last verified
- Jul 2016
- First submitted
- 15 Dec 2011
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proposed Studies on the Role of Growth Factor Receptor Trafficking in Neuroblastoma Pathogenesis
- ClinicalTrials.gov ID
- NCT01493830
- Acronym / sponsor ID
- ANBL12B4
- Conditions
- Neuroblastoma
- Keywords
- neuroblastoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2011
- Primary completion
- Jul 2016 (actual)
- First posted
- 16 Dec 2011 (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 DNA and identify biomarkers related to cancer.
PURPOSE: This research trial studies biomarkers in tumor samples from younger patients with neuroblastoma.
Detailed description
OBJECTIVES:
- To determine the expression of UBE4B, hrs, and members of the ubiquitination protein complex in previously banked primary neuroblastoma tumor samples from the Children's Oncology Group.
- To determine the correlation of expression levels and cellular localization of the UBE4B and hrs proteins with growth factor-receptor tumor cell-surface expression.
- To determine the 1p36 deletion status by fluorescence in situ hybridization (FISH) analysis and their association with expression levels of UBE4B and hrs in previously banked primary neuroblastoma tumor samples from the Children's Oncology Group.
OUTLINE: Banked tumor tissue samples are analyzed for expression of UBE4B, hrs, members of the ubiquitination protein complex, growth factor receptors, and 1p36 deletion status by immunohistochemistry (IHC), fluorescent microscopy, and fluorescence in situ hybridization (FISH).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients With Neuroblastoma
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 |
|---|---|---|
| fluorescence in situ hybridization | Genetic | – |
| gene expression analysis | Genetic | – |
| microarray analysis | Genetic | – |
| mutation analysis | Genetic | – |
| protein analysis | Genetic | – |
| immunohistochemistry staining method | Other | – |
| laboratory biomarker analysis | Other | – |
| microscopy | Other | – |
Primary outcome
Expression of UBE4B, hrs, and members of the ubiquitination protein complex
Expression levels and cellular localization of the UBE4B, hrs, and growth factor receptors
1p36 deletion status and its association with UBE4B
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 11 Jul 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.
Peter Zage, MD, PhD principal investigator
Texas Children's Cancer Center
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.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 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?
Expression of UBE4B, hrs, and members of the ubiquitination protein complex. The study lists 3 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 11 Jul 2016.