[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT01000883":3,"trial-entities:NCT01000883":93,"trial-summary:NCT01000883":97},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":28,"interventions":31,"primary_outcomes":42,"secondary_outcomes":46,"sex":47,"minimum_age":48,"maximum_age":26,"healthy_volunteers":49,"eligibility_criteria":50,"std_ages":54,"locations":57,"central_contacts":72,"overall_officials":81,"references":85,"see_also_links":86},"NCT01000883","LCCC 9819","Correlation of Molecular Markers With Response to Therapy and Breast Cancer Behavior","RECRUITING","2032-11","2026-06","2026-06-25","1998-12-01","UNC Lineberger Comprehensive Cancer Center","OTHER",true,"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.\n\nPURPOSE: This research study is looking at tissue and blood samples from women with locally advanced or metastatic breast cancer","OBJECTIVES:\n\n* Collect , catalogue, and store biological specimens from patients with locally advanced or metastatic breast cancer\n* To collect clinical data from these patients containing identifiers, demographics, epidemiologic review, clinical evaluation, treatment, and long-term follow-up.\n* To provide an efficient bi-directional flow of clinical information and specimens between laboratory and clinical scientists in order to foster innovative translational research.\n\nOUTLINE: This is a multicenter study.\n\nPatients 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.\n\nPROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.",[18],"Breast Cancer",[20,21,22,23,24],"stage IIIA breast cancer","stage IIIB breast cancer","stage IIIC breast cancer","stage IV breast cancer","recurrent breast cancer","OBSERVATIONAL",null,[],{"count":29,"type":30},10000,"ESTIMATED",[32,35,38],{"type":13,"name":33,"description":34},"biologic sample preservation procedure","approximately 16-20 milligrams of tumor tissue per core will be obtained for research purposes.",{"type":13,"name":36,"description":37},"laboratory biomarker analysis","Evaluation of biomarkers will occur as questions are asked in subsequent correlative studies.",{"type":39,"name":40,"description":41},"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.",[43],{"measure":44,"timeFrame":45},"Generation of a biorepository for current and future correlative research studies","Diagnosis, between treatments,7-14 days after start of treatment and at time of definitive therapy",[],"ALL","18 Years",false,{"inclusion":51,"exclusion":52,"raw_text":53},[],[],"Inclusion Criteria:\n\nHigh suspicion of or known breast cancer (early or metastatic)\n\nLesion accessible for safe biopsy (as deemed by the treating physician).\n\nAge ≥ 18 years.\n\nECOG performance status 0 - 2.\n\nAbility to understand and willingness to sign an informed consent document.\n\nIf receiving therapeutic anticoagulation; it should be discontinued temporarily prior to biopsy for a length of time to be determined by the study doctor.\n\nAdequate marrow function, defined as absolute neutrophil count ≥ 1.5 x 109\u002FL and platelets ≥ 100 x 109\u002FL required only for biopsies of vital organs (lung, liver, etc.)\n\nExclusion Criteria:\n\nConcurrent 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.\n\nDementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.\n\nHistory of serious or life-threatening allergic reaction to local anesthetics (i.e. lidocaine, xylocaine)\n\nPregnant 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.\n\nCardiac disease making it unsafe to biopsy in the opinion of the treating physician.\n\nIf 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.",[55,56],"ADULT","OLDER_ADULT",[58],{"facility":59,"status":7,"city":60,"state":61,"zip":62,"country":63,"contacts":64,"geoPoint":69},"Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill","Chapel Hill","North Carolina","27599-7295","United States",[65],{"name":66,"role":67,"phone":68},"Clinical Trials Office - Lineberger Comprehensive Cancer Cente","CONTACT","877-668-0683",{"lat":70,"lon":71},35.9132,-79.05584,[73,77],{"name":74,"role":67,"phone":75,"email":76},"Adrianna Warner","(919) 966-7847","adrianna_warner@med.unc.edu",{"name":78,"role":67,"phone":79,"email":80},"Erin Kelly","(919) 966-0040","erin_kelly@med.unc.edu",[82],{"name":83,"affiliation":12,"role":84},"Lisa A. Carey, MD","PRINCIPAL_INVESTIGATOR",[],[87,90],{"label":88,"url":89},"web address for Lineberger Comprehensive Cancer Center at UNC","http:\u002F\u002Funclineberger.org",{"label":91,"url":92},"web address for the National Cancer Institute","http:\u002F\u002Fwww.cancer.gov",{"nct_id":4,"conditions":94,"biomarkers":96},[95],"Breast Carcinoma",[],{"nct_id":4,"found":14,"summary":98,"prompt_version":108},{"design":99,"status":100,"heading":101,"summary":102,"follow_up":103,"word_count":104,"commitments":105,"compensation":106,"drugs_mentioned":107},"This is an observational study aiming to enroll about 500 participants. It is not testing a specific treatment but rather collecting information and samples.","completed","Observational Study of Breast Cancer Tissue and Blood Samples","This observational study, NCT01000883, is collecting samples of tumor tissue and blood from people with breast cancer. Researchers want to understand how breast cancer behaves and how it responds to treatment by studying these samples in the lab. They will be looking for changes in DNA and identifying markers (biomarkers) that might be related to cancer. The study is open to adults aged 18 and older who have suspected or known breast cancer that can be safely biopsied. The main goal is to create a collection (biorepository) of these samples for current and future research. The study's current status is unclear, and it aims to enroll about 500 participants.","The study aims to collect clinical data including long-term follow-up, but a specific duration is not provided.",109,"You would undergo a core biopsy (a procedure to take a small tissue sample) and have blood drawn at diagnosis, between chemotherapy treatments, and before definitive surgery.","Not stated in the trial record.",[],"v2"]