Wilms Tumor and Other Childhood Kidney TumorsNCT01493817
Biomarkers in Samples From Younger Patients With Wilms Tumor
An observational study of 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 younger patients with Wilms tumor. Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how patients respond to treatment Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wilms Tumor and Other Childhood Kidney Tumors
- What is being tested?
- laboratory biomarker analysis
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to 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: Wilms tumor patients
Who may be able to join
- Wilms tissue microarray samples provided by the Children's Oncology Group
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: Observational - Relationships Between Tumor-Associated Macrophages and Clinicopathological Factors in Wilms Tumor
This research study is studying biomarkers in tissue samples from younger patients with Wilms tumor. Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how patients respond to treatment
Read the detailed description
PRIMARY OBJECTIVES:
- To determine whether recruitment of tumor-associated macrophages is related to clinicopathological factors in Wilms tumor (tumor stage, presence of vascular invasion, tumor progression, and survival).
OUTLINE:
Paraffin-embedded specimens are analyzed for macrophage markers. Results of each sample are then compared with patient's tumor stage, presence of vascular invasion, tumor progression, and survival.
- 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 |
|---|---|---|
| Basic science (biomarker analysis) | Paraffin-embedded specimens are analyzed for macrophage markers. Results of each sample are then compared with patient's tumor stage, presence of vascular invasion, tumor progression, and survival. Receives: Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship of tumor-associated macrophages and prognosis
Correlation of each type of macrophage score with tumor staging, presence of vascular invasion, and disease-free survival will be assessed.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jessica Kandel, MD, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493817
- Sponsor's protocol ID
- AREN12B1
- Other IDs
- NCI-2012-00093
- Status last verified
- May 2016
- First submitted
- 15 Dec 2011
- 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
- Observational - Relationships Between Tumor-Associated Macrophages and Clinicopathological Factors in Wilms Tumor
- ClinicalTrials.gov ID
- NCT01493817
- Acronym / sponsor ID
- AREN12B1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2011
- Primary completion
- May 2016 (actual)
- First posted
- 16 Dec 2011 (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 younger patients with Wilms tumor. Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how patients respond to treatment
Detailed description
PRIMARY OBJECTIVES:
- To determine whether recruitment of tumor-associated macrophages is related to clinicopathological factors in Wilms tumor (tumor stage, presence of vascular invasion, tumor progression, and survival).
OUTLINE:
Paraffin-embedded specimens are analyzed for macrophage markers. Results of each sample are then compared with patient's tumor stage, presence of vascular invasion, tumor progression, and survival.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Basic science (biomarker analysis) | – | Other: laboratory biomarker analysisParaffin-embedded specimens are analyzed for macrophage markers. Results of each sample are then compared with patient's tumor stage, presence of vascular invasion, tumor progression, and survival. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Wilms tumor patients
Key inclusion criteria (1 listed)
- Wilms tissue microarray samples provided by the Children's Oncology Group
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 | Basic science (biomarker analysis) |
Primary outcome
Relationship of tumor-associated macrophages and prognosis
Time frame: 1 month
Correlation of each type of macrophage score with tumor staging, presence of vascular invasion, and disease-free survival will be assessed.
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.
Related trials for Wilms Tumor and Other Childhood Kidney Tumors
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Pediatric Cancer, Neuroblastoma
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.
Jessica Kandel, 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 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 1 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?
Relationship of tumor-associated macrophages and prognosis (time frame: 1 month). 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; AzTrials last refreshed its copy on 7 Nov 2026.