Kidney CancerNCT01544569
Studying Biomarkers in Samples From Young Patients With Rhabdoid Tumors
An observational study of Kidney Cancer, run by Children's Oncology Group.
Trial summary
RATIONALE: Studying samples of tissue from patients with rhabdoid tumors in the laboratory may help doctor learn more about changes that occur in DNA and identify genes related to cancer. PURPOSE: This research trial studies biomarkers in samples from young patients with rhabdoid tumors. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- DNA analysis, fluorescence in situ hybridization and gene expression analysis
- How many people
- 50 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 1 year
- All sexes
- No healthy volunteers
- Child
Study population: rhabdoid tumors
DISEASE CHARACTERISTICS:
- Freshly frozen rhabdoid tumors from either renal or extra-renal sites from children younger than 2 years of age
- Clinical patient information (age, gender, comorbidities, tumor stage, size, pathology, therapy, outcome) available
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Endogenous DNA Transposition in Rhabdoid Tumors
RATIONALE: Studying samples of tissue from patients with rhabdoid tumors in the laboratory may help doctor learn more about changes that occur in DNA and identify genes related to cancer.
PURPOSE: This research trial studies biomarkers in samples from young patients with rhabdoid tumors.
Read the detailed description
OBJECTIVES:
- To investigate the expression and function of transposons in 50 primary rhabdoid tumors.
OUTLINE: Freshly frozen rhabdoid tumors will be studied using fluorescence in situ hybridization (FISH) and polymerase chain reaction (PCR) to establish the genomic location of transposons. Protein expression in rhabdoid tumor tissue microarrays is also analyzed.
- Conditions
- Kidney Cancer
- Being tested
- DNA analysis, fluorescence in situ hybridization, gene expression analysis, gene mapping, microarray analysis
- Keywords
- rhabdoid tumor of the kidney
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA analysisGenetic
fluorescence in situ hybridizationGenetic
gene expression analysisGenetic
gene mappingGenetic
microarray analysisGenetic
polymerase chain reactionGenetic
protein expression analysisGenetic
laboratory biomarker analysisOther
medical chart reviewOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression and function of transposons in rhabdoid tumors
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 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 Kidney CancerStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Elizabeth A. Mullen, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544569
- Sponsor's protocol ID
- AREN12B3
- Other IDs
- COG-AREN12B3, CDR0000727229, AREN12B3, NCI-2012-00689
- Status last verified
- May 2016
- First submitted
- 29 Feb 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
- Endogenous DNA Transposition in Rhabdoid Tumors
- ClinicalTrials.gov ID
- NCT01544569
- Acronym / sponsor ID
- AREN12B3
- Conditions
- Kidney Cancer
- Keywords
- rhabdoid tumor of the kidney
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 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
- 6 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 tissue from patients with rhabdoid tumors in the laboratory may help doctor learn more about changes that occur in DNA and identify genes related to cancer.
PURPOSE: This research trial studies biomarkers in samples from young patients with rhabdoid tumors.
Detailed description
OBJECTIVES:
- To investigate the expression and function of transposons in 50 primary rhabdoid tumors.
OUTLINE: Freshly frozen rhabdoid tumors will be studied using fluorescence in situ hybridization (FISH) and polymerase chain reaction (PCR) to establish the genomic location of transposons. Protein expression in rhabdoid tumor tissue microarrays is also analyzed.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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 | – |
| fluorescence in situ hybridization | Genetic | – |
| gene expression analysis | Genetic | – |
| gene mapping | Genetic | – |
| microarray analysis | Genetic | – |
| polymerase chain reaction | Genetic | – |
| protein expression analysis | Genetic | – |
| laboratory biomarker analysis | Other | – |
| medical chart review | Other | – |
Primary outcome
Expression and function of transposons in rhabdoid 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 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.
Elizabeth A. Mullen, MD principal investigator
Dana-Farber Cancer Institute
Questions about this trial
What is this clinical trial studying?
An observational study of 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 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 and function of transposons in rhabdoid 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 18 May 2016.