Clear Cell Sarcoma of the KidneyNCT01118078
Biomarkers in Tissue Samples From Patients With High-Risk Wilms Tumor
An observational study of Clear Cell Sarcoma of the Kidney and Recurrent Wilms Tumor and Other Childhood Kidney Tumors, run by Children's Oncology Group at 1 site in United States.
Trial summary
This research study is studying biomarkers in tissue samples from patients with high-risk Wilms tumor. Studying samples of tissue from patients with cancer in the laboratory may help doctors to learn more about changes that occur in DNA and identify biomarkers related to cancer. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Clear Cell Sarcoma of the Kidney, Recurrent Wilms Tumor and Other Childhood Kidney Tumors, Rhabdoid Tumor of the Kidney
- What is being tested?
- DNA methylation analysis, gene expression analysis and microarray analysis
- How many people
- 185 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to 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 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Up to 80 favorable histology Wilms tumors that relapse (RFHWT), 50 anaplastic Wilms tumors (UHWT), 15 clear cell sarcomas of the kidney (CCSK), and 40 rhabdoid tumors (RT)
Who may be able to join
- Diagnosis of high-risk Wilms tumor meeting ≥ 1 of the following criteria:
- Relapsed disease
- Anaplastic disease
- Clear cell sarcomas of the kidney
- Rhabdoid tumors
- Registered on NWTS-4, NWTS-5 (now COG-Q9401), or participation in AREN03B2 protocols with clinical follow-up > 3 years
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- Banked frozen tumor samples and paired normal DNA available with clinical data points, including the following:
- Age, race, and gender
- Stage and reason for stage
- Tumor weight
- Associated precursor lesions (rests)
- Histologic subtype
- Site and time of recurrence
- Days of follow-up
- Time and reasons for death (e.g., tumor, toxicity, infection, or other)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Oncology Group
Monrovia, California, 91006-3776
About this study
Official title: Therapeutically Applicable Research to Generate Effective Treatments (TARGET) Initiative High-Risk Renal Tumor Project: Application of Array-Based Methods and Next Generation Sequencing to Identify Candidate Molecular Targets for High-Risk Wilms Tumors
This research study is studying biomarkers in tissue samples from patients with high-risk Wilms tumor. Studying samples of tissue from patients with cancer in the laboratory may help doctors to learn more about changes that occur in DNA and identify biomarkers related to cancer.
Read the detailed description
OBJECTIVES:
- To assess genomic gains and losses in high risk renal tumors, including up to 80 favorable histology Wilms tumors that relapse (RFHWT), 50 anaplastic Wilms tumors (UHWT), 15 clear cell sarcomas of the kidney (CCSK), and 40 rhabdoid tumors (RT) using a high density genetic platform to survey for recurrent copy number variations and allelic imbalances. II. To define transcription patterns within 80 RFHWT, 50 UHWT, 15 CCSK, and 40 RT using a high throughput platform for global gene expression. III. To define DNA methylation patterns within 80 RFHWT, 50 UHWT, 15 CCSK, and 40 RT using a high throughput platform. IV. To identify genetic mutations involved in the pathogenesis of Wilms tumor, and in the development of relapse and anaplasia through the study of 80 RFHWT, 50 UHWT, 15 CCSK, and 40 RT using next generation sequencing tools.
- To facilitate the integration of the above databases and allow meaningful access by investigators through the infrastructure provided by TARGET, including its data portal and associated caBIG tool.
OUTLINE: This is a multicenter study.
Archived tumor tissue samples are analyzed for DNA copy number determination, gene expression, DNA methylation, and genomic re-sequencing by array-based methods, including PCR analysis, methylation-specific reverse transcriptase-PCR (RT-PCR), and quantitative RT-PCR.
- Conditions
- Clear Cell Sarcoma of the Kidney, Recurrent Wilms Tumor and Other Childhood Kidney Tumors, Rhabdoid Tumor of the Kidney, Stage I Wilms Tumor, Stage II Wilms Tumor, Stage III Wilms Tumor
- Being tested
- DNA methylation analysis, gene expression analysis, microarray analysis, reverse transcriptase-polymerase chain reaction, diagnostic laboratory biomarker analysis
- Medical subject headings
- Wilms Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA methylation analysisGenetic
Undergo DNA methylation analysis
gene expression analysisGenetic
Undergo gene expression analysis
microarray analysisGenetic
Also called gene expression profiling
Undergo microarray analysis
reverse transcriptase-polymerase chain reactionGenetic
Also called RT-PCR
Undergo RT-PCR
diagnostic laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Biomarker (DNA methylation, gene expression, RT-PCR) | Archived tumor tissue samples are analyzed for DNA copy number determination, gene expression analysis, DNA methylation, and genomic re-sequencing by microarray analysis-based methods, including PCR analysis, DNA methylation analysis-specific RT-PCR, and quantitative RT-PCR (reverse transcriptase-polymerase chain reaction) Receives: Genetic: DNA methylation analysis; Genetic: gene expression analysis; Genetic: microarray analysis; Genetic: reverse transcriptase-polymerase chain reaction; Other: diagnostic laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genomic gains and losses in high-risk Wilms tumor
Measured: After completion of biomarker analysis
Transcription patterns involved in the pathogenesis of Wilms tumor
Measured: After completion of biomarker analysis
Genetic mutations involved in the pathogenesis of Wilms tumor
Measured: After completion of biomarker analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clear Cell Sarcoma of the KidneyStudies 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
- Prospective
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Perlman, MD, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118078
- Sponsor's protocol ID
- AREN10B2
- Other IDs
- NCI-2011-02230, CDR0000672402, U10CA098543, COG-AREN10B2
- Status last verified
- May 2016
- First submitted
- 5 May 2010
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutically Applicable Research to Generate Effective Treatments (TARGET) Initiative High-Risk Renal Tumor Project: Application of Array-Based Methods and Next Generation Sequencing to Identify Candidate Molecular Targets for High-Risk Wilms Tumors
- ClinicalTrials.gov ID
- NCT01118078
- Acronym / sponsor ID
- AREN10B2
- Conditions
- Clear Cell Sarcoma of the Kidney, Recurrent Wilms Tumor and Other Childhood Kidney Tumors, Rhabdoid Tumor of the Kidney, Stage I Wilms Tumor, Stage II Wilms Tumor, Stage III Wilms Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2010
- Primary completion
- May 2016 (actual)
- First posted
- 6 May 2010 (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.
This research study is studying biomarkers in tissue samples from patients with high-risk Wilms tumor. Studying samples of tissue from patients with cancer in the laboratory may help doctors to learn more about changes that occur in DNA and identify biomarkers related to cancer.
Detailed description
OBJECTIVES:
- To assess genomic gains and losses in high risk renal tumors, including up to 80 favorable histology Wilms tumors that relapse (RFHWT), 50 anaplastic Wilms tumors (UHWT), 15 clear cell sarcomas of the kidney (CCSK), and 40 rhabdoid tumors (RT) using a high density genetic platform to survey for recurrent copy number variations and allelic imbalances. II. To define transcription patterns within 80 RFHWT, 50 UHWT, 15 CCSK, and 40 RT using a high throughput platform for global gene expression. III. To define DNA methylation patterns within 80 RFHWT, 50 UHWT, 15 CCSK, and 40 RT using a high throughput platform. IV. To identify genetic mutations involved in the pathogenesis of Wilms tumor, and in the development of relapse and anaplasia through the study of 80 RFHWT, 50 UHWT, 15 CCSK, and 40 RT using next generation sequencing tools.
- To facilitate the integration of the above databases and allow meaningful access by investigators through the infrastructure provided by TARGET, including its data portal and associated caBIG tool.
OUTLINE: This is a multicenter study.
Archived tumor tissue samples are analyzed for DNA copy number determination, gene expression, DNA methylation, and genomic re-sequencing by array-based methods, including PCR analysis, methylation-specific reverse transcriptase-PCR (RT-PCR), and quantitative RT-PCR.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biomarker (DNA methylation, gene expression, RT-PCR) | – | Genetic: DNA methylation analysis, Genetic: gene expression analysis, Genetic: microarray analysis, Genetic: reverse transcriptase-polymerase chain reaction, Other: diagnostic laboratory biomarker analysisArchived tumor tissue samples are analyzed for DNA copy number determination, gene expression analysis, DNA methylation, and genomic re-sequencing by microarray analysis-based methods, including PCR analysis, DNA methylation analysis-specific RT-PCR, and quantitative RT-PCR (reverse transcriptase-polymerase chain reaction) |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Up to 80 favorable histology Wilms tumors that relapse (RFHWT), 50 anaplastic Wilms tumors (UHWT), 15 clear cell sarcomas of the kidney (CCSK), and 40 rhabdoid tumors (RT)
Key inclusion criteria (15 listed)
- Diagnosis of high-risk Wilms tumor meeting ≥ 1 of the following criteria:
- Registered on NWTS-4, NWTS-5 (now COG-Q9401), or participation in AREN03B2 protocols with clinical follow-up > 3 years
- Banked frozen tumor samples and paired normal DNA available with clinical data points, including the following:
Key exclusion criteria (0 listed)
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 methylation analysisUndergo DNA methylation analysis | Genetic | Biomarker (DNA methylation, gene expression, RT-PCR) |
| gene expression analysisUndergo gene expression analysis | Genetic | Biomarker (DNA methylation, gene expression, RT-PCR) |
| microarray analysisAlso: gene expression profilingUndergo microarray analysis | Genetic | Biomarker (DNA methylation, gene expression, RT-PCR) |
| reverse transcriptase-polymerase chain reactionAlso: RT-PCRUndergo RT-PCR | Genetic | Biomarker (DNA methylation, gene expression, RT-PCR) |
| diagnostic laboratory biomarker analysisCorrelative studies | Other | Biomarker (DNA methylation, gene expression, RT-PCR) |
Primary outcome
Genomic gains and losses in high-risk Wilms tumor
Time frame: After completion of biomarker analysis
Transcription patterns involved in the pathogenesis of Wilms tumor
Time frame: After completion of biomarker analysis
Genetic mutations involved in the pathogenesis of Wilms tumor
Time frame: After completion of biomarker analysis
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 19 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 Perlman, MD principal investigator
Children's Oncology Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clear Cell Sarcoma of the Kidney and Recurrent Wilms Tumor and Other Childhood Kidney Tumors, run by Children's Oncology Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. 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 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Genomic gains and losses in high-risk Wilms tumor (time frame: After completion of biomarker analysis). The study lists 3 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 19 May 2016.