Correlation of Molecular Markers With Response to Therapy and Breast Cancer Behavior
RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This research study is looking at tissue and blood samples from women with locally advanced or metastatic breast cancer
|Breast Cancer||Other: biologic sample preservation procedure Other: laboratory biomarker analysis Procedure: biopsy|
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Correlation of Molecular Markers With Response to Therapy and Breast Cancer Behavior|
- Generation of a biorepository for current and future correlative research studies [ Time Frame: Diagnosis, between treatments,7-14 days after start of treatment and at time of definitive therapy ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||December 1998|
|Estimated Study Completion Date:||November 2022|
|Estimated Primary Completion Date:||November 2020 (Final data collection date for primary outcome measure)|
Other: biologic sample preservation procedure
- Collect , catalogue, and store biological specimens from patients with locally advanced or metastatic breast cancer
- To collect clinical data from these patients containing identifiers, demographics, epidemiologic review, clinical evaluation, treatment, and long-term follow-up.
- To provide an efficient bi-directional flow of clinical information and specimens between laboratory and clinical scientists in order to foster innovative translational research.
OUTLINE: This is a multicenter study.
Patients undergo core biopsy and blood sampling at diagnosis, between chemotherapy regimens, and prior to definitive surgery. Tumor markers are assessed using immunohistochemistry and flow cytometry.
PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01000883
|Contact: Dale Flowers, RN||(919) email@example.com|
|Contact: Diane Winans||(919) firstname.lastname@example.org|
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Recruiting|
|Chapel Hill, North Carolina, United States, 27599-7295|
|Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente 877-668-0683|
|Nash Heathcare||Active, not recruiting|
|Rocky Mount, North Carolina, United States, 27804|
|Principal Investigator:||Lisa A. Carey, MD||UNC Lineberger Comprehensive Cancer Center|