Biomarkers in Samples From Younger Patients With Wilms Tumor
May 17, 2016 updated by: Children's Oncology Group
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
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. 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 Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Monrovia, California, United States, 91006-3776
- Children's Oncology Group
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Wilms tumor patients
Description
Inclusion Criteria:
- Wilms tissue microarray samples provided by the Children's Oncology Group
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
Correlative studies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jessica Kandel, MD, Children's Oncology Group
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
December 15, 2011
First Submitted That Met QC Criteria
December 15, 2011
First Posted (Estimate)
December 16, 2011
Study Record Updates
Last Update Posted (Estimate)
May 19, 2016
Last Update Submitted That Met QC Criteria
May 17, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AREN12B1
- NCI-2012-00093 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.