Biomarkers in Samples From Younger Patients With Wilms Tumor

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01493817
First received: December 15, 2011
Last updated: May 7, 2015
Last verified: May 2015
  Purpose

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


Condition Intervention
Wilms Tumor and Other Childhood Kidney Tumors
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Observational - Relationships Between Tumor-Associated Macrophages and Clinicopathological Factors in Wilms Tumor

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Relationship of tumor-associated macrophages and prognosis [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Correlation of each type of macrophage score with tumor staging, presence of vascular invasion, and disease-free survival will be assessed.


Estimated Enrollment: 30
Study Start Date: December 2011
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Wilms tumor patients

Criteria

Inclusion Criteria:

  • Wilms tissue microarray samples provided by the Children's Oncology Group
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493817

Locations
United States, California
Children's Oncology Group Recruiting
Monrovia, California, United States, 91006-3776
Contact: Jessica J. Kandel, MD    212-342-8585    jjk47@columbia.edu   
Principal Investigator: Jessica J. Kandel, MD         
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Jessica Kandel, MD Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01493817     History of Changes
Other Study ID Numbers: AREN12B1, NCI-2012-00093
Study First Received: December 15, 2011
Last Updated: May 7, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Neoplasms
Wilms Tumor
Genetic Diseases, Inborn
Kidney Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Complex and Mixed
Neoplastic Syndromes, Hereditary
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on May 21, 2015