NCT01493817

Brief 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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2011

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

May 19, 2016

Status Verified

May 1, 2016

Enrollment Period

4.4 years

First QC Date

December 15, 2011

Last Update Submit

May 17, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

Correlative studies

Basic science (biomarker analysis)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Wilms tumor patients

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Oncology Group

Monrovia, California, 91006-3776, United States

Location

MeSH Terms

Conditions

Wilms Tumor

Condition Hierarchy (Ancestors)

Neoplasms, Complex and MixedNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplastic Syndromes, HereditaryFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Jessica Kandel, MD

    Children's Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2011

First Posted

December 16, 2011

Study Start

December 1, 2011

Primary Completion

May 1, 2016

Last Updated

May 19, 2016

Record last verified: 2016-05

Locations