Kidney CancerNCT01550393
Biomarkers in Urine Samples From Patients With Wilms Tumor
An observational study of Kidney Cancer, run by Children's Oncology Group.
Trial summary
RATIONALE: Studying samples of urine from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer. PURPOSE: This clinical trial studies biomarkers in urine from patients with Wilms tumor. Read more about this study
- Who is it for?
- Ages Up to 120 years
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- proteomic profiling, enzyme-linked immunosorbent assay and laboratory biomarker analysis
- How many people
- 100 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 with stage II-III Wilms tumors
DISEASE CHARACTERISTICS:
- Urine specimens collected at diagnosis will be selected from patients with stage II-III Wilms tumors, with both local and non-local sites of disease relapse
- Clinical patient information (urinalysis/macro, age, gender, congenital defects/syndromes, comorbidities, tumor stage, size, pathology, therapy, outcome) available
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Discovery and Validation of Wilms Tumor Markers Using Urine Proteomics
RATIONALE: Studying samples of urine from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer.
PURPOSE: This clinical trial studies biomarkers in urine from patients with Wilms tumor.
Read the detailed description
OBJECTIVES:
- To validate the prognostic performance of specific-candidate Wilms tumor markers by measuring their urinary concentration using enzyme-linked immunosorbent assays (ELISAs) in urine specimens collected at diagnosis from 50 patients with favorable histology Wilms tumor who relapsed and 50 patients who did not relapse.
OUTLINE: Urine specimens are analyzed using enzyme-linked immunosorbent assays (ELISAs) for biomarkers.
- Conditions
- Kidney Cancer
- Being tested
- proteomic profiling, enzyme-linked immunosorbent assay, laboratory biomarker analysis, medical chart review
- Keywords
- stage II Wilms tumor, stage III Wilms tumor, recurrent Wilms tumor and other childhood kidney tumors
- 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.
proteomic profilingGenetic
enzyme-linked immunosorbent assayOther
laboratory biomarker analysisOther
medical chart reviewOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Wilms tumor biomarkers identified by ELISA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 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 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
- 100 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
- NCT01550393
- Sponsor's protocol ID
- AREN12B4
- Other IDs
- COG-AREN12B4, CDR0000727337, AREN12B4, NCI-2012-00702
- Status last verified
- Jul 2016
- First submitted
- 6 Mar 2012
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discovery and Validation of Wilms Tumor Markers Using Urine Proteomics
- ClinicalTrials.gov ID
- NCT01550393
- Acronym / sponsor ID
- AREN12B4
- Conditions
- Kidney Cancer
- Keywords
- stage II Wilms tumor, stage III Wilms tumor, recurrent Wilms tumor and other childhood kidney tumors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 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
- 12 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 urine from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer.
PURPOSE: This clinical trial studies biomarkers in urine from patients with Wilms tumor.
Detailed description
OBJECTIVES:
- To validate the prognostic performance of specific-candidate Wilms tumor markers by measuring their urinary concentration using enzyme-linked immunosorbent assays (ELISAs) in urine specimens collected at diagnosis from 50 patients with favorable histology Wilms tumor who relapsed and 50 patients who did not relapse.
OUTLINE: Urine specimens are analyzed using enzyme-linked immunosorbent assays (ELISAs) for biomarkers.
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 with stage II-III Wilms 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 |
|---|---|---|
| proteomic profiling | Genetic | – |
| enzyme-linked immunosorbent assay | Other | – |
| laboratory biomarker analysis | Other | – |
| medical chart review | Other | – |
Primary outcome
Wilms tumor biomarkers identified by ELISA
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 11 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.
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 11 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?
Wilms tumor biomarkers identified by ELISA. 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 11 Jul 2016.