Brain and Central Nervous System TumorsNCT01553175
Studying Gene Expression in Samples From Patients With Rhabdoid Tumors
An observational study of Brain and Central Nervous System Tumors and Kidney Cancer, 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 find 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 120 years
- Conditions the study is for
- Brain and Central Nervous System Tumors, Kidney Cancer
- What is being tested?
- DNA analysis, gene expression analysis and mutation analysis
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to 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 diagnosed with rhabdoid tumors
DISEASE CHARACTERISTICS:
- Tumor samples from patients diagnosed with rhabdoid tumors
- Matched frozen tumor tissue from BRG1-negative tumors (preferred) or matched genomic DNA from tumors, 100 ng per tumor from BRG1-negative tumors
- Any source of DNA from BRG1-negative tumors (tumors, blood, etc.)
- Matched frozen tumor tissue from BRM-negative tumors to confirm that BRM is not mutated or altered but rather epigenetically suppressed when lost in rhabdoid tumors
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Determination of the Frequency of BRG1 and BRM Loss in Rhabdoid Tumors
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 find 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 patients with rhabdoid tumors.
Read the detailed description
OBJECTIVES:
- To determine if BRM is silenced in the majority, if not all, rhabdoid tumors by immunohistochemistry in primary tumors.
- To determine if BRG1 is silenced in the majority, if not all, rhabdoid tumors by immunohistochemistry in primary tumors.
- To determine if GATA1 and/or HDAC2 is overexpressed in the same tumors that lack BRM expression.
- To determine if BRM promoter polymorphisms correlate with loss of BRM expression in primary rhabdoid tumors.
- To determine how BRG1 is silenced in primary rhabdoid tumors by sequencing BRG1 exons in genomic DNA derived from frozen samples.
OUTLINE: Archived tumor tissue samples are analyzed for BRM, BRG1, GATA1, and/or HDAC2 expression by immunohistochemistry. BRM- and BRG1-negative samples are also analyzed.
- Being tested
- DNA analysis, gene expression analysis, mutation analysis, protein expression analysis, immunohistochemistry staining method
- Keywords
- childhood atypical teratoid/rhabdoid tumor, rhabdoid tumor of the kidney
- Medical subject headings
- Central Nervous System Neoplasms, Kidney Neoplasms, Rhabdoid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA analysisGenetic
gene expression analysisGenetic
mutation analysisGenetic
protein expression analysisGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence or presence BRG1 and BRM expression in rhabdoid tumors
Mechanism of suppression of BRG1 and BRM genes
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 completionJul 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David Reisman, MD, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553175
- Sponsor's protocol ID
- AREN12B5
- Other IDs
- COG-AREN12B5, CDR0000728521, NCI-2012-00705
- Status last verified
- Jul 2016
- First submitted
- 10 Mar 2012
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Frequency of BRG1 and BRM Loss in Rhabdoid Tumors
- ClinicalTrials.gov ID
- NCT01553175
- Acronym / sponsor ID
- AREN12B5
- Keywords
- childhood atypical teratoid/rhabdoid tumor, rhabdoid tumor of the kidney
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2012
- Primary completion
- Jul 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 tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and find 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 patients with rhabdoid tumors.
Detailed description
OBJECTIVES:
- To determine if BRM is silenced in the majority, if not all, rhabdoid tumors by immunohistochemistry in primary tumors.
- To determine if BRG1 is silenced in the majority, if not all, rhabdoid tumors by immunohistochemistry in primary tumors.
- To determine if GATA1 and/or HDAC2 is overexpressed in the same tumors that lack BRM expression.
- To determine if BRM promoter polymorphisms correlate with loss of BRM expression in primary rhabdoid tumors.
- To determine how BRG1 is silenced in primary rhabdoid tumors by sequencing BRG1 exons in genomic DNA derived from frozen samples.
OUTLINE: Archived tumor tissue samples are analyzed for BRM, BRG1, GATA1, and/or HDAC2 expression by immunohistochemistry. BRM- and BRG1-negative samples are also analyzed.
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 diagnosed with rhabdoid 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 |
|---|---|---|
| DNA analysis | Genetic | – |
| gene expression analysis | Genetic | – |
| mutation analysis | Genetic | – |
| protein expression analysis | Genetic | – |
| immunohistochemistry staining method | Other | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Absence or presence BRG1 and BRM expression in rhabdoid tumors
Mechanism of suppression of BRG1 and BRM genes
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 14 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.
David Reisman, MD, PhD principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
An observational study of Brain and Central Nervous System Tumors and Kidney Cancer, 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 14 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?
Absence or presence BRG1 and BRM expression in rhabdoid tumors. 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 14 Jul 2016.