Expired Study
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Little Rock, Arkansas 72205


Purpose:

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.


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.


Study is Available At:


Original ID:

111481


NCT ID:

NCT01141530


Secondary ID:


Study Acronym:


Brief Title:

Deep Sequencing of the Breast Cancer Transcriptome


Official Title:

Deep Sequencing of the Breast Cancer Transcriptome


Overall Status:

Withdrawn


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Arkansas


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Study withdrawn due to inability to enroll s


Study Type:

Observational


Study Design:

Observational Model: Case-Only, Time Perspective:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

0


Enrollment Type:

Actual


Study Dates

Start Date:September 2009
Completion Date:December 2013
Completion Type:Actual
Primary Completion Date:December 2013
Primary Completion Type:Actual
Verification Date:December 2013
Last Changed Date:December 3, 2013
First Received Date:June 9, 2010

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Other
Name:No intervention
Description: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.
Arm Name:Tissue Bank Samples

Study Arms

Study Arm Type:Other
Arm Name:Tissue Bank Samples
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Arkansas

Samples and Retentions

Sample Retention:Samples With DNA
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.
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.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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