Deep Sequencing of the Breast Cancer Transcriptome

This study has been withdrawn prior to enrollment.
(Study withdrawn due to inability to enroll subjects.)
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01141530
First received: June 9, 2010
Last updated: December 3, 2013
Last verified: December 2013
  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.


Condition Intervention
Breast Cancer
Other: No intervention

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Deep Sequencing of the Breast Cancer Transcriptome

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

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.


Enrollment: 0
Study Start Date: September 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01141530

Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
  More Information

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01141530     History of Changes
Other Study ID Numbers: 111481
Study First Received: June 9, 2010
Last Updated: December 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arkansas:
Identify novel genes and predict putative proteins in breast cancer.
Find biomarkers that can be used for early detection, diagnosis, and prognosis.

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 30, 2014