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Correlation of Molecular Markers With Response to Therapy and Breast Cancer Behavior
RECRUITINGSponsored by UNC Lineberger Comprehensive Cancer Center
Actively Recruiting
SponsorUNC Lineberger Comprehensive Cancer Center
Started1998-12-01
Est. completion2030-11
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT01000883
Summary
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
Eligibility
Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria: High suspicion of or known breast cancer (early or metastatic) Lesion accessible for safe biopsy (as deemed by the treating physician). Age ≥ 18 years. ECOG performance status 0 - 2. Ability to understand and willingness to sign an informed consent document. If receiving therapeutic anticoagulation; it should be discontinued temporarily prior to biopsy for a length of time to be determined by the study doctor. Adequate marrow function, defined as absolute neutrophil count ≥ 1.5 x 109/L and platelets ≥ 100 x 109/L required only for biopsies of vital organs (lung, liver, etc.) Exclusion Criteria: Concurrent disease or condition that would make the patient inappropriate for study participation or any serious medical or psychiatric disorder that would interfere with the subject's safety. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent. History of serious or life-threatening allergic reaction to local anesthetics (i.e. lidocaine, xylocaine) Pregnant women are excluded because there may be an increased risk to both mother and fetus in the setting of conscious sedation, which is required for biopsies of certain anatomic sites (e.g. liver, lung). Also, ionizing radiation from CT-guided biopsies may pose a risk to the unborn fetus. Cardiac disease making it unsafe to biopsy in the opinion of the treating physician. If patients receiving bevacizumab or other angiogenesis inhibitors are less than 6 weeks from last dose of the angiogenesis inhibitor, they should not undergo research core biopsies of vital organs (lung, liver, etc.) on this protocol because of the concern for the possibility of increased bleeding risk and delayed healing. Patients receiving bevacizumab or other angiogenesis inhibitors who are undergoing a research biopsy of the breast, peripheral lymph node or a skin punch biopsy must be two weeks from the last dose of the angiogenesis inhibitor.
Conditions2
Breast CancerCancer
Locations1 site
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295
Clinical Trials Office - Lineberger Comprehensive Cancer Cente877-668-0683
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Actively Recruiting
SponsorUNC Lineberger Comprehensive Cancer Center
Started1998-12-01
Est. completion2030-11
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT01000883