Brain and Central Nervous System TumorsNCT01585389
Studying Gene Expression and Location in Samples From Patients With Brain Tumors
An observational study of Brain and Central Nervous System Tumors, run by Children's Oncology Group.
Trial summary
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to brain tumors. PURPOSE: This research studies gene expression and location in samples from patients with brain tumors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- gene expression analysis, genetic linkage analysis and microarray analysis
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Apr 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: Patients diagnosed with brain tumors
DISEASE CHARACTERISTICS:
- Tissue microarrays (TMA) samples from the Biopathology Core
- Samples from patients diagnosed with brain tumors
- Progenitor, or blast, cell origin
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Expression and Subcellular Localization of NEIL3 in Tumors
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to brain tumors.
PURPOSE: This research studies gene expression and location in samples from patients with brain tumors.
Read the detailed description
OBJECTIVES:
- To determine the expression and subcellular localization of nei endonuclease VIII-like 3 (NEIL3) in brain tumors.
OUTLINE: Tissue microarray samples are analyzed for NEIL3 expression and subcellular localization by immunohistochemical methods.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- gene expression analysis, genetic linkage analysis, microarray analysis, immunohistochemistry staining method, laboratory biomarker analysis
- Keywords
- adult brain tumor, childhood brain tumor
- Medical subject headings
- Central Nervous System Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene expression analysisGenetic
genetic linkage analysisGenetic
microarray analysisGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of NEIL3 expression and/or nuclear localization with tumor type or grade with respect to degree of differentiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2012 (estimated)
- Study startApr 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 Brain and Central Nervous System TumorsStudies 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Heithem M. El-Hodiri, PhD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585389
- Sponsor's protocol ID
- ABTR12B3
- Other IDs
- COG-ABTR12B3, ABTR12B3, CDR0000732178, NCI-2012-00731
- Status last verified
- May 2016
- First submitted
- 24 Apr 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
- Expression and Subcellular Localization of NEIL3 in Tumors
- ClinicalTrials.gov ID
- NCT01585389
- Acronym / sponsor ID
- ABTR12B3
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- adult brain tumor, childhood brain tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2012
- Primary completion
- May 2016 (actual)
- First posted
- 25 Apr 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 identify and learn more about biomarkers related to brain tumors.
PURPOSE: This research studies gene expression and location in samples from patients with brain tumors.
Detailed description
OBJECTIVES:
- To determine the expression and subcellular localization of nei endonuclease VIII-like 3 (NEIL3) in brain tumors.
OUTLINE: Tissue microarray samples are analyzed for NEIL3 expression and subcellular localization by immunohistochemical methods.
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
- Patients diagnosed with brain tumors
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 | – |
| genetic linkage analysis | Genetic | – |
| microarray analysis | Genetic | – |
| immunohistochemistry staining method | Other | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Correlation of NEIL3 expression and/or nuclear localization with tumor type or grade with respect to degree of differentiation
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.
Heithem M. El-Hodiri, PhD principal investigator
Nationwide Children's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Brain and Central Nervous System Tumors, 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 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?
Correlation of NEIL3 expression and/or nuclear localization with tumor type or grade with respect to degree of differentiation. 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.