Neoplastic SyndromeNCT01553448
Studying Gene Expression in Samples From Younger Patients With Neuroblastoma
An observational study of Neoplastic Syndrome and Neuroblastoma, run by Children's Oncology Group.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Neoplastic Syndrome, Neuroblastoma
- What is being tested?
- gene expression analysis, protein expression analysis and enzyme-linked immunosorbent assay
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Mar 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
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
About this study
Official title: The Role of Stroma-Derived Soluble TßRIII in Neuroblastoma
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.
Read the detailed description
OBJECTIVES:
- Determine whether TβRIII expression and TGF-β signaling decrease in advanced-stage neuroblastoma (NBL) and whether these changes are confined to the Schwannian stroma.
- Determine whether sTβRIII levels and TGF-β signaling correlate with NBL stage, tumor stroma content, surface TβRIII expression, and TGF-β signaling.
OUTLINE: Archived paraffin-embedded tissue and plasma samples are analyzed for TβRIII expression, TGF-β signaling, and SMAD3 expression and phosphorylation by immunohistochemistry, enzyme-linked immunosorbent assay (ELISA), and other assays. Surface expression of TβRIII in the neuroblastic and stromal tumor components are correlated with matched circulating levels of soluble TβRIII. Results are then correlated with each patient's outcome data, including stage.
- Conditions
- Neoplastic Syndrome, Neuroblastoma
- Being tested
- gene expression analysis, protein expression analysis, enzyme-linked immunosorbent assay, immunohistochemistry staining method, laboratory biomarker analysis
- Keywords
- disseminated neuroblastoma, hereditary neuroblastoma, localized resectable neuroblastoma, localized unresectable neuroblastoma, stage 4S neuroblastoma
- Medical subject headings
- Neoplasms, Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene expression analysisGenetic
protein expression analysisGenetic
enzyme-linked immunosorbent assayOther
laboratory biomarker analysisOther
medical chart reviewOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplastic SyndromeStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Gerard C. Blobe, MD, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553448
- Sponsor's protocol ID
- ANBL12B6
- Other IDs
- COG-ANBL12B6, CDR0000728527, ANBL12B6, NCI-2012-00706
- Status last verified
- May 2016
- First submitted
- 13 Mar 2012
- 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
- The Role of Stroma-Derived Soluble TßRIII in Neuroblastoma
- ClinicalTrials.gov ID
- NCT01553448
- Acronym / sponsor ID
- ANBL12B6
- Conditions
- Neoplastic Syndrome, Neuroblastoma
- Keywords
- disseminated neuroblastoma, hereditary neuroblastoma, localized resectable neuroblastoma, localized unresectable neuroblastoma, stage 4S neuroblastoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2012
- Primary completion
- May 2016 (actual)
- First posted
- 14 Mar 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 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.
Detailed description
OBJECTIVES:
- Determine whether TβRIII expression and TGF-β signaling decrease in advanced-stage neuroblastoma (NBL) and whether these changes are confined to the Schwannian stroma.
- Determine whether sTβRIII levels and TGF-β signaling correlate with NBL stage, tumor stroma content, surface TβRIII expression, and TGF-β signaling.
OUTLINE: Archived paraffin-embedded tissue and plasma samples are analyzed for TβRIII expression, TGF-β signaling, and SMAD3 expression and phosphorylation by immunohistochemistry, enzyme-linked immunosorbent assay (ELISA), and other assays. Surface expression of TβRIII in the neuroblastic and stromal tumor components are correlated with matched circulating levels of soluble TβRIII. Results are then correlated with each patient's outcome data, including stage.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
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 |
|---|---|---|
| gene expression analysis | Genetic | – |
| protein expression analysis | Genetic | – |
| enzyme-linked immunosorbent assay | Other | – |
| immunohistochemistry staining method | Other | – |
| laboratory biomarker analysis | Other | – |
| medical chart review | Other | – |
Primary outcome
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
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.
Gerard C. Blobe, MD, PhD principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplastic Syndrome and 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?
Expression of TβRIII in the neuroblastic tumor and stroma of patients with advanced-stage NBL. 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 18 May 2016.