NeuroblastomaNCT01407731
Protein Expression in Human Neuroblastoma Tumor Samples
An observational study of Neuroblastoma, run by Children's Oncology Group.
Trial summary
RATIONALE: Studying protein expression in 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. It may also help doctors find better ways to treat neuroblastoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neuroblastoma
- What is being tested?
- protein expression analysis, western blotting and laboratory biomarker analysis
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Diagnosed with neuroblastoma.
DISEASE CHARACTERISTICS:
- Diagnosed with neuroblastoma
- Banked primary tumor samples from patients with stage 1, 2, 3, and 4 disease
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Analysis of Intersectin Expression in Primary Human Neuroblastomas
RATIONALE: Studying protein expression in 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. It may also help doctors find better ways to treat neuroblastoma.
PURPOSE: This laboratory studying is looking at protein expression in tumor tissue samples from patients with neuroblastoma.
Read the detailed description
OBJECTIVES:
- To determine whether intersectin (ITSN1) proteins are present at elevated levels in primary human tumor samples.
OUTLINE: Archived tumor tissue samples are analyzed for intersectin (ITSN1) expression by western blot assays with enhanced chemiluminescence and exposed to X-ray film. The films are scanned, and levels of ITSN1 signal are quantified by densitometry.
- Conditions
- Neuroblastoma
- Being tested
- protein expression analysis, western blotting, laboratory biomarker analysis
- Keywords
- disseminated neuroblastoma, localized resectable neuroblastoma, localized unresectable 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.
protein expression analysisGenetic
western blottingGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
ITSN1 is highly expressed in neuroblastoma tumors and plays an important role in the development/progression of these tumors
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2011 (estimated)
- Study startJul 2011
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- John P. O'Bryan, PhD, Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407731
- Sponsor's protocol ID
- ANBL11B4
- Other IDs
- COG-ANBL11B4, ANBL11B4, NCI-2011-03799
- Status last verified
- May 2016
- First submitted
- 30 Jul 2011
- 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
- Analysis of Intersectin Expression in Primary Human Neuroblastomas
- ClinicalTrials.gov ID
- NCT01407731
- Acronym / sponsor ID
- ANBL11B4
- Conditions
- Neuroblastoma
- Keywords
- disseminated neuroblastoma, localized resectable neuroblastoma, localized unresectable neuroblastoma, stage 4S neuroblastoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2011
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 2 Aug 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 protein expression in 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. It may also help doctors find better ways to treat neuroblastoma.
PURPOSE: This laboratory studying is looking at protein expression in tumor tissue samples from patients with neuroblastoma.
Detailed description
OBJECTIVES:
- To determine whether intersectin (ITSN1) proteins are present at elevated levels in primary human tumor samples.
OUTLINE: Archived tumor tissue samples are analyzed for intersectin (ITSN1) expression by western blot assays with enhanced chemiluminescence and exposed to X-ray film. The films are scanned, and levels of ITSN1 signal are quantified by densitometry.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Diagnosed 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 |
|---|---|---|
| protein expression analysis | Genetic | – |
| western blotting | Genetic | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
ITSN1 is highly expressed in neuroblastoma tumors and plays an important role in the development/progression of these tumors
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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Neuroblastoma
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.
John P. O'Bryan, PhD principal investigator
University of Illinois at Chicago
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?
ITSN1 is highly expressed in neuroblastoma tumors and plays an important role in the development/progression of these tumors. 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.