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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01493817
Other study ID # AREN12B1
Secondary ID NCI-2012-00093
Status Completed
Phase N/A
First received December 15, 2011
Last updated May 17, 2016
Start date December 2011

Study information

Verified date May 2016
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Wilms tissue microarray samples provided by the Children's Oncology Group

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Other:
laboratory biomarker analysis
Correlative studies

Locations

Country Name City State
United States Children's Oncology Group Monrovia California

Sponsors (2)

Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 month No
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