NeuroblastomaNCT01387724
Biomarkers in Blood and Tissue Samples From Patients With Newly Diagnosed Neuroblastoma
An observational study of Neuroblastoma, run by Children's Oncology Group.
Trial summary
RATIONALE: Studying samples of blood and 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 blood and tissue samples from patients with newly diagnosed neuroblastoma. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Neuroblastoma
- What is being tested?
- RNA analysis, polymerase chain reaction and protein expression analysis
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to 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 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with newly diagnosed neuroblastoma or ganglioneuroblastoma.
DISEASE CHARACTERISTICS:
- Children with newly diagnosed neuroblastoma or ganglioneuroblastoma
- Samples from the Children's Oncology Group (COG) from patients enrolled in clinical trials in institutions in the USA, Canada, and Australia
- Paraffin-embedded tumor specimens, RNA isolated from tumor tissues, and patient serum must be available
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Neuropeptide Y and Its Receptors in Neuroblastoma
RATIONALE: Studying samples of blood and 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 blood and tissue samples from patients with newly diagnosed neuroblastoma.
Read the detailed description
OBJECTIVES:
- Determine the expression of neuropeptide Y (NPY) and its receptors (Rs) in human neuroblastoma (NB) tissues.
- Determine whether BDNF/TrkB and TrkAIII stimulate expression of NPY and its Rs.
- Determine whether NPY mediates BDNF- and TrkAIII-induced NB proliferation and survival.
- Determine neurotrophins' angiogenic actions.
- Identify factors released from NB cells upon NPY stimulation (proteomics).
- Determine whether NPY upregulates expression of the identified proteins in NB and their Rs in endothelial cells (ECs).
- Test whether inhibition of the identified pathways reduces angiogenic activity of NB-conditioned media.
- Determine the mechanisms of NYP actions and signaling pathways.
- Test whether blocking NPY-Y2/Y5 pathway reduces NB growth and vascularization in vivo.
OUTLINE: Archived tumor tissue and serum samples are analyzed for neuropeptide Y and its receptors (Y1, Y2, and Y5) expression, neuroblastoma prognostic factors (MYCN, TrkA, TrkAIII, TrkB, BDNF, and NGF), and angiogenic markers by real-time PCR, IHC, ELISA, radioimmunoassay (RIA), mitogenic assay, caspase 3/7 activity assay, western blots, liquid chromatography, tandem mass spectrometry, proteomic assays, and other assays. Results are then analyzed and compared with patients' clinical data, including stage of disease, its phenotype, prognostic markers, age and gender, and response to treatment.
- Conditions
- Neuroblastoma
- Being tested
- RNA analysis, polymerase chain reaction, protein expression analysis, proteomic profiling, western blotting
- Keywords
- disseminated neuroblastoma, localized resectable neuroblastoma, localized unresectable 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
polymerase chain reactionGenetic
protein expression analysisGenetic
proteomic profilingGenetic
western blottingGenetic
enzyme-linked immunosorbent assayOther
laboratory biomarker analysisOther
liquid chromatographyOther
mass spectrometryOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of high expression of NPY and its Y2/Y5 Rs in NBs with poor outcome of the disease, advanced stage, increased vascularization and other unfavorable prognostic factors, such as TrkB expression and MYCN amplification
BDNF/TrkB and TrkAIII up-regulate expression of NPY and its Rs
NPY upregulates expression of the identified proteins in NB and their Rs in endothelial cells (ECs)
Interaction between Y2 and Y5 receptors in NB and ECs sensitize them to NPY and amplify NPY-induced proliferation
Blocking the NPY-Y2/Y5 pathway reduces NB growth and tumor vascularization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2011 (estimated)
- Study startJun 2011
- Primary 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Joanna Kitlinska, PhD, Principal investigator, Lombardi Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387724
- Sponsor's protocol ID
- ANBL11B1
- Other IDs
- COG-ANBL11B1, NCI-2011-02862, ANBL11B1
- Status last verified
- May 2016
- First submitted
- 1 Jul 2011
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropeptide Y and Its Receptors in Neuroblastoma
- ClinicalTrials.gov ID
- NCT01387724
- Acronym / sponsor ID
- ANBL11B1
- Conditions
- Neuroblastoma
- Keywords
- disseminated neuroblastoma, localized resectable neuroblastoma, localized unresectable neuroblastoma, regional neuroblastoma, stage 4S neuroblastoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2011
- Primary completion
- May 2016 (actual)
- First posted
- 4 Jul 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 blood and 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 blood and tissue samples from patients with newly diagnosed neuroblastoma.
Detailed description
OBJECTIVES:
- Determine the expression of neuropeptide Y (NPY) and its receptors (Rs) in human neuroblastoma (NB) tissues.
- Determine whether BDNF/TrkB and TrkAIII stimulate expression of NPY and its Rs.
- Determine whether NPY mediates BDNF- and TrkAIII-induced NB proliferation and survival.
- Determine neurotrophins' angiogenic actions.
- Identify factors released from NB cells upon NPY stimulation (proteomics).
- Determine whether NPY upregulates expression of the identified proteins in NB and their Rs in endothelial cells (ECs).
- Test whether inhibition of the identified pathways reduces angiogenic activity of NB-conditioned media.
- Determine the mechanisms of NYP actions and signaling pathways.
- Test whether blocking NPY-Y2/Y5 pathway reduces NB growth and vascularization in vivo.
OUTLINE: Archived tumor tissue and serum samples are analyzed for neuropeptide Y and its receptors (Y1, Y2, and Y5) expression, neuroblastoma prognostic factors (MYCN, TrkA, TrkAIII, TrkB, BDNF, and NGF), and angiogenic markers by real-time PCR, IHC, ELISA, radioimmunoassay (RIA), mitogenic assay, caspase 3/7 activity assay, western blots, liquid chromatography, tandem mass spectrometry, proteomic assays, and other assays. Results are then analyzed and compared with patients' clinical data, including stage of disease, its phenotype, prognostic markers, age and gender, and response to treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with newly diagnosed neuroblastoma or ganglioneuroblastoma.
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 | – |
| polymerase chain reaction | Genetic | – |
| protein expression analysis | Genetic | – |
| proteomic profiling | Genetic | – |
| western blotting | Genetic | – |
| enzyme-linked immunosorbent assay | Other | – |
| immunohistochemistry staining method | Other | – |
| laboratory biomarker analysis | Other | – |
| liquid chromatography | Other | – |
| mass spectrometry | Other | – |
Primary outcome
Association of high expression of NPY and its Y2/Y5 Rs in NBs with poor outcome of the disease, advanced stage, increased vascularization and other unfavorable prognostic factors, such as TrkB expression and MYCN amplification
BDNF/TrkB and TrkAIII up-regulate expression of NPY and its Rs
NPY upregulates expression of the identified proteins in NB and their Rs in endothelial cells (ECs)
Interaction between Y2 and Y5 receptors in NB and ECs sensitize them to NPY and amplify NPY-induced proliferation
Blocking the NPY-Y2/Y5 pathway reduces NB growth and tumor vascularization
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 18 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.
Joanna Kitlinska, PhD principal investigator
Lombardi Comprehensive 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 18 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?
Association of high expression of NPY and its Y2/Y5 Rs in NBs with poor outcome of the disease, advanced stage, increased vascularization and other unfavorable prognostic factors, such as TrkB expression and MYCN amplification. The study lists 5 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 18 May 2016.