Correlation of Molecular Markers With Response to Therapy and Breast Cancer Behavior
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01000883|
Recruitment Status : Recruiting
First Posted : October 23, 2009
Last Update Posted : June 9, 2022
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
|Condition or disease||Intervention/treatment|
|Breast Cancer||Other: biologic sample preservation procedure Other: laboratory biomarker analysis Procedure: biopsy|
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||10000 participants|
|Official Title:||Correlation of Molecular Markers With Response to Therapy and Breast Cancer Behavior|
|Actual Study Start Date :||December 1, 1998|
|Estimated Primary Completion Date :||November 2030|
|Estimated Study Completion Date :||November 2032|
- Other: biologic sample preservation procedure
approximately 16-20 milligrams of tumor tissue per core will be obtained for research purposes.
- Other: laboratory biomarker analysis
Evaluation of biomarkers will occur as questions are asked in subsequent correlative studies.
- Procedure: biopsy
cancer tissue will be taken from the primary breast cancer site as well as the metastatic tumor sites. Two tubes of whole blood will also be collected.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01000883
|Contact: Adrianna Warner||(919) firstname.lastname@example.org|
|Contact: Erin Kelly||(919) email@example.com|
|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|
|Principal Investigator:||Lisa A. Carey, MD||UNC Lineberger Comprehensive Cancer Center|