Deep Sequencing of the Breast Cancer Transcriptome | NCT01141530

Studies
Deep Sequencing of the Breast Cancer Transcriptome

NCT01141530

Sponsor

University of Arkansas

Status

Withdrawn

Last Update Posted

Dec 5, 2013Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

No intervention

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

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study withdrawn due to inability to enroll subjects.

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jun 9, 2010

First Submission Date that Met QC Criteria

Jun 9, 2010

First Posted Date

Jun 10, 2010Estimated

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

Dec 3, 2013

Last Update Posted Date

Dec 5, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This project is a pilot study designed to investigate transcriptional regulation in breast cancer. Although the main focus of the present study will be triple negative breast cancer where all of the clinically relevant receptors - estrogen receptor (ER), progesterone receptor (PR) and herceptin (HER2) - are absent, all breast tissue biospecimens, including normal and mammary dysplasia, stored in the UAMS Tissue bank, procured from outside collaborators or purchased from commercial vendors will eventually be investigated. We will use high throughput molecular profiling techniques such as microarrays and next generation sequencing to correlate gene expression and gene expression regulation with clinical parameters such as tumor size, time to relapse and overall survival.

Detailed Description

Not provided

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

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tissue Bank Samples		Because this study is a retrospective tissue bank study, there are no subjects actively participating in this study. All samples studied will be obtained through the UAMS Tissue Bank.	Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	Because this study is a retrospective tissue bank study, there are no subjects actively participating in this study, thus no intervention. All samples studied will be obtained through the UAMS Tissue Bank.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

There is no inclusion criteria. This study is a retrospective tissue bank study analyzing tissue collected from a previous clinical trial. No subjects will be enrolled.

Exclusion Criteria:

There is no exclusion criteria. This study is a retrospective tissue bank study analyzing tissue collected from a previous clinical trial. No subjects will be enrolled.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

This study is a retrospective tissue bank study analyzing tissue collected from a previous clinical trial. No subjects will be enrolled. Tissue was collected during biopsies or mastectomies after pathologist's approval.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Arkansas for Medical Sciences		Little Rock	Arkansas	72205	United States

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D004194	Disease

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Description

The informed consent process for biospecimen collection we expect to use in this research has already been obtained by the UAMS Tissue Bank personnel as a part of the UARK 2005-06 protocol. Tissue is collected during biopsies or mastectomies after pathologist approval. We will sequence small non-coding molecules (microRNA), messenger RNA, chromatin immunoprecipated and bisulfite treated DNA.