Recurrent Wilms Tumor and Other Childhood Kidney TumorsNCT00897637
Gene Expression Profiles to Categorize Wilms Tumors
An observational study of Recurrent Wilms Tumor and Other Childhood Kidney Tumors and Stage I Wilms Tumor, run by Children's Oncology Group at 2 sites in United States.
Trial summary
This laboratory study is using gene expression profiling to identify different categories of Wilms tumors. Studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Recurrent Wilms Tumor and Other Childhood Kidney Tumors, Stage I Wilms Tumor, Stage II Wilms Tumor
- What is being tested?
- laboratory biomarker analysis
- How many people
- 600 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2004to 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: Specimens from patients previously enrolled as "On Study" or "Followed Biology Only" on protocol NWTSG-5 (COG-Q9401)
Who may be able to join
- Specimens from patients previously enrolled as "On Study" or "Followed Biology Only" on protocol NWTSG-5 (COG-Q9401)
- Study follow-up data for disease status available
- National Wilms Tumor Study Group/Children's Oncology Group pathology review showing "favorable" histology
- Sufficient biology samples available without using biology bank reserves
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Oncology Group
Arcadia, California, 91006-3776
Saint Mary's Hospital
West Palm Beach, Florida, 33407
About this study
Official title: Categorization of Wilms Tumors by Genetic Expression
This laboratory study is using gene expression profiling to identify different categories of Wilms tumors. Studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer.
Read the detailed description
OBJECTIVES:
- Identify new molecular categories of Wilms tumor (WT) based on the gene expression profiles of samples from patients with this disease.
II. Develop a classifying system (classifier) that will predict a defined number of clinically relevant categories based on expression of an established set of genes.
III. Confirm and test the classifier with further analysis of the genes by several different methodologies, using additional patient samples that are outside of the case/cohort but which possess the clinically or scientifically relevant parameter.
IV. Validate the use of the classifier to predict defined groups within a second set of samples (for which investigators are blinded to the clinical and biological data) by subsequent comparison with true incidence of pertinent markers.
OUTLINE:
Three hundred tumor specimens are analyzed for genetic expression profiles using Affymetrix assays. Specific genes are identified as classifiers and analyzed using tissue arrays. An additional 300 specimens are examined for gene expression and categorized according to the classifiers.
- Conditions
- 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
- Being tested
- 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.
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Observational | Three hundred tumor specimens are analyzed for genetic expression profiles using Affymetrix assays. Specific genes are identified as classifiers and analyzed using tissue arrays. An additional 300 specimens are examined for gene expression and categorized according to the classifiers. Receives: Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
New molecular categories of Wilms tumor identified and measured by gene expression profiles
Measured: Up to 6 years
Identification of genes that as a whole provide strong prediction of outcomes of interest
Supervised methods such as CART or Shrunken Centroid Classifier will be used.
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startFeb 2004
- Primary completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Wilms Tumor and Other Childhood Kidney 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 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
- NCT00897637
- Sponsor's protocol ID
- AREN03B1
- Other IDs
- NCI-2009-00415, CDR0000349184, COG-AREN03B1, U10CA098543
- Status last verified
- May 2016
- First submitted
- 9 May 2009
- 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
- Categorization of Wilms Tumors by Genetic Expression
- ClinicalTrials.gov ID
- NCT00897637
- Acronym / sponsor ID
- AREN03B1
- Conditions
- 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
- 600 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2004
- Primary completion
- May 2016 (actual)
- First posted
- 12 May 2009 (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 laboratory study is using gene expression profiling to identify different categories of Wilms tumors. Studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer.
Detailed description
OBJECTIVES:
- Identify new molecular categories of Wilms tumor (WT) based on the gene expression profiles of samples from patients with this disease.
II. Develop a classifying system (classifier) that will predict a defined number of clinically relevant categories based on expression of an established set of genes.
III. Confirm and test the classifier with further analysis of the genes by several different methodologies, using additional patient samples that are outside of the case/cohort but which possess the clinically or scientifically relevant parameter.
IV. Validate the use of the classifier to predict defined groups within a second set of samples (for which investigators are blinded to the clinical and biological data) by subsequent comparison with true incidence of pertinent markers.
OUTLINE:
Three hundred tumor specimens are analyzed for genetic expression profiles using Affymetrix assays. Specific genes are identified as classifiers and analyzed using tissue arrays. An additional 300 specimens are examined for gene expression and categorized according to the classifiers.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: laboratory biomarker analysisThree hundred tumor specimens are analyzed for genetic expression profiles using Affymetrix assays. Specific genes are identified as classifiers and analyzed using tissue arrays. An additional 300 specimens are examined for gene expression and categorized according to the classifiers. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Specimens from patients previously enrolled as "On Study" or "Followed Biology Only" on protocol NWTSG-5 (COG-Q9401)
Key inclusion criteria (4 listed)
- Specimens from patients previously enrolled as "On Study" or "Followed Biology Only" on protocol NWTSG-5 (COG-Q9401)
- National Wilms Tumor Study Group/Children's Oncology Group pathology review showing "favorable" histology
- Sufficient biology samples available without using biology bank reserves
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 |
|---|---|---|
| laboratory biomarker analysisCorrelative studies | Other | Observational |
Primary outcome
New molecular categories of Wilms tumor identified and measured by gene expression profiles
Time frame: Up to 6 years
Identification of genes that as a whole provide strong prediction of outcomes of interest
Time frame: Up to 6 years
Supervised methods such as CART or Shrunken Centroid Classifier will be used.
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Wilms Tumor and Other Childhood Kidney Tumors and Stage I Wilms Tumor, run by Children's Oncology Group at 2 sites 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 4 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 2 sites 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?
New molecular categories of Wilms tumor identified and measured by gene expression profiles (time frame: Up to 6 years). 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 19 May 2016.