Studying Biomarkers in Samples From Younger Patients With... | NCT01642095

Studies
Studying Biomarkers in Samples From Younger Patients With Kidney Cancer

NCT01642095

Sponsor

Children's Oncology Group

Status

Withdrawn

Last Update Posted

Aug 7, 2018Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Childhood Kidney Neoplasm
Clear Cell Renal Cell Carcinoma
Congenital Mesoblastic Nephroma
Rhabdoid Tumor of the Kidney

Interventions

Laboratory Biomarker Analysis

Countries

United States

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
NCI-2012-01987	Registry Identifier	CTRP (Clinical Trial Reporting Program)
CDR0000736805
AREN12B8
COG-AREN12B8
AREN12B8	Other Identifier	Childrens Oncology Group
AREN12B8	Other Identifier	CTEP

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 22, 2012Actual

Primary Completion Date

Sep 1, 2012Actual

Completion Date

Not provided

First Submitted Date

Jul 15, 2012

First Submission Date that Met QC Criteria

Jul 15, 2012

First Posted Date

Jul 17, 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

Aug 3, 2018

Last Update Posted Date

Aug 7, 2018Actual

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

Brief Summary

This laboratory study is looking into biomarkers in samples from younger patients with kidney cancer. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer.

Detailed Description

PRIMARY OBJECTIVES:

I. To determine whether focal adhesion kinase (FAK) is expressed and if FAK is phosphorylated in pediatric renal tumors.

OUTLINE:

Archived tumor tissue samples are analyzed for FAK expression by immunohistochemistry (IHC). IHC staining is compared in normal renal tissue, Wilms tumor (routine and anaplastic), malignant rhabdoid tumor of the kidney, clear cell sarcoma of the kidney, and mesoblastic nephroma.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Basic science (FAK expression)		Archived tumor tissue samples are analyzed for FAK expression by IHC. IHC staining is compared in normal renal tissue, Wilms tumor (routine and anaplastic), malignant rhabdoid tumor of the kidney, clear cell sarcoma of the kidney, and mesoblastic nephroma.	Other: Laboratory Biomarker Analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laboratory Biomarker Analysis	Other	Correlative studies	Basic science (FAK expression)

Measure	Description	Time Frame
FAK expression in pediatric renal tumors		Baseline

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Formalin-fixed, paraffin-embedded tissue samples from patients diagnosed with the following renal tumors:
- Anaplastic Wilms tumor
- Malignant rhabdoid tumor of the kidney
- Clear cell sarcoma of the kidney
- Mesoblastic nephroma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elizabeth Beierle	Children's Oncology Group	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Childrens Oncology Group		Philadelphia	Pennsylvania	19104	United States

Condition Browse Module

MeSH Terms

ID	Term
D002292	Carcinoma, Renal Cell
D018201	Nephroma, Mesoblastic

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided