NCT01141530

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2010

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 5, 2013

Status Verified

December 1, 2013

Enrollment Period

4.3 years

First QC Date

June 9, 2010

Last Update Submit

December 3, 2013

Conditions

Keywords

Identify novel genes and predict putative proteins in breast cancer.Find biomarkers that can be used for early detection, diagnosis, and prognosis.

Study Arms (1)

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

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.

Tissue Bank Samples

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Breast NeoplasmsDisease

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2010

First Posted

June 10, 2010

Study Start

September 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 5, 2013

Record last verified: 2013-12

Locations