[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT01503190":3,"trial-entities:NCT01503190":106,"trial-summary:NCT01503190":110},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":26,"primary_purpose":15,"phases":27,"enrollment_info":28,"interventions":31,"primary_outcomes":32,"secondary_outcomes":37,"sex":38,"minimum_age":39,"maximum_age":15,"healthy_volunteers":40,"eligibility_criteria":41,"std_ages":45,"locations":48,"central_contacts":100,"overall_officials":102,"references":104,"see_also_links":105},"NCT01503190","09-0583.cc","The Immune System's Response to Young Women's Breast Cancer","A Translational Study of the Interactions Between Prior Pregnancy and the Biologic Subtype of Breast Cancer in Defining the Cancer: Host Immunologic Interaction","RECRUITING","2027-07","2026-01","2026-01-29","2009-07-21","University of Colorado, Denver","OTHER",null,"This study plans to learn more about the immune system's response to breast cancer in young women.","The investigators will be looking at the level of immune suppression in different types of breast cancer. The investigators will use blood, urine, and tissue samples from patients with Pregnancy Associated Breast Cancer (PABC) versus non-PABC, as well as comparing different types of breast cancer. If tissue sampling permits, the investigators may use some of the breast cancer tissue to develop models for human cancer for drug targeting. Understanding the immune response and suppression in different types of cancer will help us understand mechanisms involved in breast cancer better and help the investigators in developing new treatment in the future.",[19,20],"Breast Cancer","Breast Cancer and Pregnancy",[19,22,23,24,25],"Young Women","Pregnancy Associated Breast Cancer","Pregnancy","Premenopausal Breast Cancer","OBSERVATIONAL",[],{"count":29,"type":30},800,"ESTIMATED",[],[33],{"measure":34,"description":35,"timeFrame":36},"Progression Free Survival","Prospective cohort study.","Throughout study participation",[],"FEMALE","18 Years",false,{"inclusion":42,"exclusion":43,"raw_text":44},[],[],"Inclusion Criteria:\n\n1. Females \\>18.\n2. Histological or cytological confirmation of breast cancer.\n3. For patients diagnosed with needle core or excisional biopsy, formalin-fixed paraffin embedded tumor blocks or unstained slides should be available or planned to be available after upcoming procedure.\n4. Patient should be willing to have fresh and\u002For fresh frozen tissue collected at time of core biopsy, definitive breast cancer surgery or clinically planned breast cancer metastasis biopsy\u002Fresection for research purposes as part of study procedures, if a procedure is in the future planning of the patient's treatment.\n5. Any clinical stage allowed.\n6. Written informed consent obtained prior to any initiation of study procedures in the case of subjects consented in clinic. Subjects consented outside of UCH, VVMC or SCC will be consented by phone and verbal informed consent will be obtained prior to any initiation of study procedures.\n7. Women treated at UCH, VVMC or SCC may be pregnant. Other participants are excluded for safety reasons.\n8. Women who have commenced or completed their breast cancer treatment may join this study by consenting to a retrospective tissue donation only consent of the protocol.\n9. Women who receive their care at a facility other than UCH, VVMC or SCC may join this study. These women will be consented utilizing the phone consent and will receive a copy of the consent in the mail, or they will consent online and print a copy of their online consent.\n\nExclusion Criteria:\n\n1. Known significant autoimmune condition \\[ie Lupus, Crohne's disease or Rhuematoid Arthritis\\], chronic oral steroid use, use of systemic immunomodulatory prescription drugs for any medical condition.\n2. The presence of other comorbid conditions known to significantly impact immune function, (such as: type I diabetes, uncontrolled adult onset diabetes, severe COPD, uncontrolled infection or known HIV infection.)\n3. Underlying psychiatric condition which would, in the opinion of the investigator, preclude compliance with study requirements\n4. Subjects with a history of other malignancy besides current diagnosis of breast cancer who were diagnosed and treated within the last 5 years are excluded, with exception of cervical cancer definitively treated more than 2 years ago or non-melanomatous skin cancer.",[46,47],"ADULT","OLDER_ADULT",[49,67,76,82,91],{"facility":50,"status":8,"city":51,"state":52,"zip":53,"country":54,"contacts":55,"geoPoint":64},"University of Colorado Denver","Aurora","Colorado","80045","United States",[56,61],{"name":57,"role":58,"phone":59,"email":60},"Hannah Parris","CONTACT","720-848-4170","hannah.parris@cuanschutz.edu",{"name":62,"role":63},"Virginia Borges, MD, MMSc","PRINCIPAL_INVESTIGATOR",{"lat":65,"lon":66},39.72943,-104.83192,{"facility":68,"status":8,"city":69,"state":52,"zip":70,"country":54,"contacts":71,"geoPoint":73},"Denver Health Hospital Authority","Denver","80204",[72],{"name":57,"role":58,"phone":59,"email":60},{"lat":74,"lon":75},39.73915,-104.9847,{"facility":77,"status":8,"city":69,"state":52,"zip":78,"country":54,"contacts":79,"geoPoint":81},"UCHealth Cherry Creek Medcial Center","80206",[80],{"name":57,"role":58,"phone":59,"email":60},{"lat":74,"lon":75},{"facility":83,"status":8,"city":84,"state":52,"zip":85,"country":54,"contacts":86,"geoPoint":88},"UCHealth Highlands Ranch Hospital","Highlands Ranch","80129",[87],{"name":57,"role":58,"phone":59,"email":60},{"lat":89,"lon":90},39.55388,-104.96943,{"facility":92,"status":8,"city":93,"state":52,"zip":94,"country":54,"contacts":95,"geoPoint":97},"UCHealth Lone Tree Medical Center","Lone Tree","80124",[96],{"name":57,"role":58,"phone":59,"email":60},{"lat":98,"lon":99},39.55171,-104.8863,[101],{"name":57,"role":58,"phone":59,"email":60},[103],{"name":62,"affiliation":13,"role":63},[],[],{"nct_id":4,"conditions":107,"biomarkers":109},[108],"Breast Carcinoma",[],{"nct_id":4,"found":111,"summary":112,"prompt_version":122},true,{"design":113,"status":114,"heading":115,"summary":116,"follow_up":117,"word_count":118,"commitments":119,"compensation":120,"drugs_mentioned":121},"This is an observational study, meaning researchers will collect information without giving any specific treatments. It plans to enroll 800 women.","completed","Understanding the Immune System's Response to Breast Cancer in Young Women","This observational study aims to understand how the immune system responds to breast cancer in young women. Researchers will look at how much the immune system is suppressed in different types of breast cancer, including those related to pregnancy (Pregnancy Associated Breast Cancer or PABC). They will use blood, urine, and tissue samples to compare PABC with non-PABC cases, and also compare different types of breast cancer. This research will help scientists better understand how breast cancer works and could lead to new treatments in the future. You may be able to join if you are a woman over 18 with a confirmed breast cancer diagnosis and have tissue samples available. The main goal is to see how long people live without their cancer getting worse (Progression Free Survival) throughout the study.","The study will track how long participants live without their cancer getting worse (Progression Free Survival) throughout their participation.",132,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]