Biomarkers in Urine Samples From Patients With Wilms Tumor | NCT01550393

Studies
Biomarkers in Urine Samples From Patients With Wilms Tumor

NCT01550393

Sponsor

Children's Oncology Group

Status

Completed

Last Update Posted

Jul 11, 2016Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Kidney Cancer

Interventions

proteomic profiling
enzyme-linked immunosorbent assay
laboratory biomarker analysis
medical chart review

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
COG-AREN12B4	Other Identifier	Children's Oncology Group
CDR0000727337	Other Identifier	Clinical Trials.gov
AREN12B4	Other Identifier	Children's Oncology Group
NCI-2012-00702	Registry Identifier	CTRP (Clinical Trial Reporting Program)

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Jul 2016Actual

Completion Date

Not provided

First Submitted Date

Mar 6, 2012

First Submission Date that Met QC Criteria

Mar 7, 2012

First Posted Date

Mar 12, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2016

Last Update Posted Date

Jul 11, 2016Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

RATIONALE: Studying samples of urine from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer.

PURPOSE: This clinical trial studies biomarkers in urine from patients with Wilms tumor.

Detailed Description

OBJECTIVES:

To validate the prognostic performance of specific-candidate Wilms tumor markers by measuring their urinary concentration using enzyme-linked immunosorbent assays (ELISAs) in urine specimens collected at diagnosis from 50 patients with favorable histology Wilms tumor who relapsed and 50 patients who did not relapse.

OUTLINE: Urine specimens are analyzed using enzyme-linked immunosorbent assays (ELISAs) for biomarkers.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
proteomic profiling	Genetic
enzyme-linked immunosorbent assay	Other
laboratory biomarker analysis	Other
medical chart review	Other

Measure	Description	Time Frame
Wilms tumor biomarkers identified by ELISA

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Urine specimens collected at diagnosis will be selected from patients with stage II-III Wilms tumors, with both local and non-local sites of disease relapse
Clinical patient information (urinalysis/macro, age, gender, congenital defects/syndromes, comorbidities, tumor stage, size, pathology, therapy, outcome) available

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

Not specified

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

120 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with stage II-III Wilms tumors

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elizabeth A. Mullen, MD	Dana-Farber Cancer Institute	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007680	Kidney Neoplasms
D009396	Wilms Tumor

Ancestor Terms

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004797	Enzyme-Linked Immunosorbent Assay

Ancestor Terms

ID	Term
D007124	Immunoenzyme Techniques
D007118	Immunoassay
D007158	Immunologic Techniques
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided