Kidney CancerNCT01542333
Studying Biomarkers in Samples From Younger Patients With Wilms Tumor
An observational study of Kidney Cancer, run by Children's Oncology Group.
Trial summary
RATIONALE: Studying samples of tissue and urine from patients with cancer in the laboratory may help doctor learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research trial studies biomarkers in samples from younger patients with Wilms tumor. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- gene expression analysis, proteomic profiling and reverse transcriptase-polymerase chain reaction
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Feb 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: Diagnosed with Wilms tumor
DISEASE CHARACTERISTICS:
- Diagnosed with Wilms tumor
- Specimens from African-American and from Caucasian children
- Specimens from each ethnicity who relapsed
- Specimens from each ethnicity who did NOT relapse
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Biological Analysis of Ethnic Variations in Wilms Tumor
RATIONALE: Studying samples of tissue and urine from patients with cancer in the laboratory may help doctor learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research trial studies biomarkers in samples from younger patients with Wilms tumor.
Read the detailed description
OBJECTIVES:
- To determine a unique molecular "finger print" of primary Wilms tumor arising in ethnically diverse children who are at increased risk to develop this lethal malignancy and subsequently relapse.
- To determine a unique protein "finger print" from the urine of ethnically diverse children who develop Wilms tumor and subsequent relapse.
OUTLINE: Formalin-fixed paraffin-embedded and snap-frozen primary tissue samples, and urine samples collected at the time of diagnosis and before treatment, are analyzed for molecular and protein profile by MALDI-TOF mass spectroscopy, western blotting, immunohistochemistry, and reverse-transcriptase polymerase chain reaction (RT-PCR) assays.
- Conditions
- Kidney Cancer
- Being tested
- gene expression analysis, proteomic profiling, reverse transcriptase-polymerase chain reaction, western blotting, immunohistochemistry staining method
- Keywords
- recurrent Wilms tumor and other childhood kidney tumors, stage I Wilms tumor, stage II Wilms tumor, stage III Wilms tumor, stage IV Wilms tumor, stage V Wilms tumor
- Medical subject headings
- Kidney Neoplasms, Wilms Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene expression analysisGenetic
proteomic profilingGenetic
reverse transcriptase-polymerase chain reactionGenetic
western blottingGenetic
laboratory biomarker analysisOther
spectroscopyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular "finger print" of primary Wilms tumor in ethnically diverse children
Protein "finger print" from the urine of ethnically diverse children
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startFeb 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Harold N. Lovvorn, III, MD, Principal investigator, Vanderbilt Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542333
- Sponsor's protocol ID
- AREN12B2
- Other IDs
- COG-AREN12B2, CDR0000726713, AREN12B2, NCI-2012-00686
- Status last verified
- May 2016
- First submitted
- 22 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
- Biological Analysis of Ethnic Variations in Wilms Tumor
- ClinicalTrials.gov ID
- NCT01542333
- Acronym / sponsor ID
- AREN12B2
- Conditions
- Kidney Cancer
- Keywords
- recurrent Wilms tumor and other childhood kidney tumors, stage I Wilms tumor, stage II Wilms tumor, stage III Wilms tumor, stage IV Wilms tumor, stage V Wilms tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2012
- Primary completion
- May 2016 (actual)
- First posted
- 2 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 and urine from patients with cancer in the laboratory may help doctor learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research trial studies biomarkers in samples from younger patients with Wilms tumor.
Detailed description
OBJECTIVES:
- To determine a unique molecular "finger print" of primary Wilms tumor arising in ethnically diverse children who are at increased risk to develop this lethal malignancy and subsequently relapse.
- To determine a unique protein "finger print" from the urine of ethnically diverse children who develop Wilms tumor and subsequent relapse.
OUTLINE: Formalin-fixed paraffin-embedded and snap-frozen primary tissue samples, and urine samples collected at the time of diagnosis and before treatment, are analyzed for molecular and protein profile by MALDI-TOF mass spectroscopy, western blotting, immunohistochemistry, and reverse-transcriptase polymerase chain reaction (RT-PCR) assays.
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 Wilms tumor
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 | – |
| proteomic profiling | Genetic | – |
| reverse transcriptase-polymerase chain reaction | Genetic | – |
| western blotting | Genetic | – |
| immunohistochemistry staining method | Other | – |
| laboratory biomarker analysis | Other | – |
| spectroscopy | Procedure or surgery | – |
Primary outcome
Molecular "finger print" of primary Wilms tumor in ethnically diverse children
Protein "finger print" from the urine of ethnically diverse children
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.
Harold N. Lovvorn, III, MD principal investigator
Vanderbilt Children's Hospital
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.
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?
Molecular "finger print" of primary Wilms tumor in ethnically diverse children. 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.