Studying Genes in Samples From Younger Patients With Adre... | NCT01528956

Studies
Studying Genes in Samples From Younger Patients With Adrenocortical Tumor

NCT01528956

Sponsor

Children's Oncology Group

Status

Completed

Last Update Posted

May 18, 2016Estimated

Enrollment

10Estimated

Phase

Not provided

Conditions

Adrenocortical Carcinoma

Interventions

DNA methylation analysis
RNA analysis
gene expression analysis
nucleic acid sequencing
polymorphism analysis

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-ARAR12B1	Other Identifier	Children's Oncology Group
CDR0000724572	Other Identifier	Clinical trials.gov
ARAR12B1	Other Identifier	Children's Oncology Group
NCI-2012-00244	Registry Identifier	CTRP (Clinical Trial Reporting Program)

Status Module

Record Verification Date

May 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

Feb 2012

Primary Completion Date

May 2016Actual

Completion Date

Not provided

First Submitted Date

Feb 5, 2012

First Submission Date that Met QC Criteria

Feb 5, 2012

First Posted Date

Feb 8, 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

May 17, 2016

Last Update Posted Date

May 18, 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 and tumor 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.

PURPOSE: This research trial studies genes in samples from younger patients with adrenocortical tumor.

Detailed Description

OBJECTIVES:

To perform whole-genome sequencing, deep sequencing, micro RNA analysis, methylation status, copy number variation analysis, and single-nucleotide polymorphisms (SNPs) analysis in pediatric adrenocortical tumors and compare those results to those of the same patient's normal cells.

OUTLINE: Archived tumor and blood samples are analyzed for whole-genome sequencing, deep sequencing, micro RNA , methylation status, copy variation, and single-nucleotide polymorphisms. Results are then compared with patients' normal cells.

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

10Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DNA methylation analysis	Genetic
RNA analysis	Genetic
gene expression analysis	Genetic
nucleic acid sequencing	Genetic
polymorphism analysis	Genetic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Identification of genetic factors affecting adrenocortical tumors
Comprehensive catalog of altered genes in adrenocortical samples

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Banked tumor and blood samples obtained from patients enrolled on COG-ARAR0332 in North America and Brazil

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

21 Years

Standard Ages

ChildAdult

Study Population

Patients enrolled on COG-ARAR0332

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gerard Zambetti, PhD	St. Jude Children's Research Hospital	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018268	Adrenocortical Carcinoma

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

Intervention Browse Module

MeSH Terms

ID	Term
D019175	DNA Methylation
D020869	Gene Expression Profiling
D001483	Base Sequence
D054458	Amplified Fragment Length Polymorphism Analysis

Ancestor Terms

ID	Term
D008745	Methylation
D000478	Alkylation
D001669	Biochemical Phenomena
D055598	Chemical Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided