Studying Biomarkers in Samples From Younger Patients With... | NCT01576198

Studies
Studying Biomarkers in Samples From Younger Patients With Wilms Tumor

NCT01576198

Sponsor

Children's Oncology Group

Status

Completed

Last Update Posted

Jul 14, 2016Estimated

Enrollment

2,227Estimated

Phase

Not provided

Conditions

Kidney Cancer

Interventions

DNA analysis
nucleic acid amplification
diagnostic 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-AREN11B3	Other Identifier	Children's Oncology Group
NCI-2012-00725	Registry Identifier	CTRP (Clinical Trial Reporting Program)
AREN11B3	Other Identifier	Children's Oncology Group

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

Apr 2012

Primary Completion Date

Jul 2016Actual

Completion Date

Not provided

First Submitted Date

Apr 11, 2012

First Submission Date that Met QC Criteria

Apr 11, 2012

First Posted Date

Apr 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 13, 2016

Last Update Posted Date

Jul 14, 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 blood, tissue, or bone marrow from patients with cancer in the laboratory may help doctors to learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies biomarkers in samples from younger patients with Wilms tumor.

Detailed Description

OBJECTIVES:

To analyze 250 favorable-histology Wilms tumor (FHWT) samples from patients registered on NWTS4 for gain of 1q and 15q, and loss of 1p, 16q, 17p, and 22q by subtelomeric multiplex ligation-dependent probe amplification (MLPA), and to determine their association with relapse-free and overall survival.
To develop a robust multiplex MLPA test using multiple synthesized probes to those targets identified as significantly associated with relapse in Aim 1.
To validate the multiplex MLPA test designed and tested in Aim 2 on an independent set of 1727 FHWT and 250 anaplastic WT registered on NWTS-5.

OUTLINE: Archived DNA samples are analyzed for gain of 1q and 15q, and loss of 1p, 16q, 17p, and 22q by MLPA. Assay results are then researched for accuracy, clinical validity, sensitivity, precision, and potential analytical interferences.

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

No data available

No data is available for this block.

Enrollment

2,227Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DNA analysis	Genetic
nucleic acid amplification	Genetic
diagnostic laboratory biomarker analysis	Other
medical chart review	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Validation of copy number changes (gain of 1q and 15q, and loss of 1p, 16q, 17p, and 22q) in FHWT by the MLPA assay

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

DNA samples from FHWT patients registered on:
- NWTS-4
- NWTS-5 with focal and diffuse anaplasia tumors

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 Wilms Tumor

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elizabeth J. Perlman, MD	Ann & Robert H Lurie Children's Hospital of Chicago	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
D021141	Nucleic Acid Amplification Techniques

Ancestor Terms

ID	Term
D005821	Genetic Techniques
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided