Biomarkers in Samples From Younger Patients With Wilms Tumor

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01493817
First received: December 15, 2011
Last updated: May 17, 2016
Last verified: May 2016
  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.


Enrollment: 30
Study Start Date: December 2011
Primary Completion Date: May 2016 (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

Ages Eligible for Study:   Child, Adult, Senior
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
Monrovia, California, United States, 91006-3776
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jessica Kandel, MD Children's Oncology Group
  More Information

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 17, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 22, 2016