[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100125194":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":20,"centralContacts":7,"locations":24,"responsibleParty":38,"collaborators":7,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":7,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":7,"studyType":54,"phases":7,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":65,"whyStopped":7,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Mayo Clinic","OTHER",null,[9,11,13,15,17],{"type":6,"name":10,"description":7,"armGroupLabels":7,"otherNames":7},"high performance liquid chromatography",{"type":6,"name":12,"description":7,"armGroupLabels":7,"otherNames":7},"laboratory biomarker analysis",{"type":6,"name":14,"description":7,"armGroupLabels":7,"otherNames":7},"mass spectrometry",{"type":6,"name":16,"description":7,"armGroupLabels":7,"otherNames":7},"medical chart review",{"type":18,"name":19,"description":7,"armGroupLabels":7,"otherNames":7},"PROCEDURE","evaluation of cancer risk factors",[21],{"name":22,"affiliation":5,"role":23},"Sandhya Pruthi, MD","PRINCIPAL_INVESTIGATOR",[25],{"facility":26,"status":7,"city":27,"state":28,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":7},"Mayo Clinic Cancer Center","Rochester","Minnesota","55905","United States","US",{"type":33,"coordinates":34},"Point",[35,36],-92.4699,44.02163,{"lat":36,"lon":35},{"type":39,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100125194","studying-biomarkers-in-nipple-fluid-urine-and-blood-samples-from-women-with-newly-diagnosed-ductal-carcinoma-in-situ-or-stage-i-or-stage-ii-breast-cancer-and-in-women-at-risk-of-developing-breast-cancer-100125194",false,"NCT00897208","Studying Biomarkers in Nipple Fluid, Urine, and Blood Samples From Women With Newly Diagnosed Ductal Carcinoma In Situ or Stage I or Stage II Breast Cancer and in Women at Risk of Developing Breast Cancer","Estrogen-DNA Adducts in Breast, Urine and Serum as Biomarkers of Breast Cancer Risk","DISEASE CHARACTERISTICS:\n\n* Meets 1 of the following criteria:\n\n  * Newly diagnosed (within 30 calendar days of diagnosis) stage I or II breast cancer\n\n    * Node-negative or node-positive disease\n  * Newly diagnosed ductal carcinoma in situ (stage 0) of the breast\n  * At high risk of developing breast cancer, as indicated by at least 1 of the following criteria:\n\n    * Gail model 5-year risk score ≥ 1.66%\n    * Gail model lifetime-risk estimate ≥ 20%\n    * Known deleterious BRCA 1 or 2 gene mutation carrier\n    * History of lobular carcinoma in situ or atypical ductal or lobular hyperplasia\n  * At low or average risk of developing breast cancer (control group)\n\n    * Gail model 5-year risk score \\\u003C 1.66% or lifetime risk \\\u003C 20%\n* No advanced breast cancer\n* Hormone receptor status not specified\n\nPATIENT CHARACTERISTICS:\n\n* Pre- or post-menopausal\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior chemotherapy for breast cancer or any other cancer\n* More than 3 months since prior and no concurrent estrogen or other hormones\n* More than 3 months since prior oral contraceptives\n* No concurrent selective estrogen receptor modulators (tamoxifen citrate or raloxifene)\n* No concurrent aromatase inhibitors",true,"FEMALE","19 Years","80 Years",{"count":52,"type":53},316,"ACTUAL","OBSERVATIONAL","RATIONALE: Studying samples of nipple fluid, urine, and blood in the laboratory from patients with cancer and from patients at risk of developing cancer may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors learn more about breast cancer and identify patients at risk of developing breast cancer.\n\nPURPOSE: This laboratory study is looking at biomarkers in nipple fluid, urine, and blood samples from women with newly diagnosed ductal carcinoma in situ or stage I or stage II breast cancer and in women at risk of developing breast cancer.",[57],"Breast Cancer",[59,60,61,62,63,64],"breast cancer","ductal breast carcinoma in situ","breast cancer in situ","stage IA breast cancer","stage IB breast cancer","stage II breast cancer","COMPLETED","2018-10-04",{"date":68,"type":53},"2018-10-05",{"date":70,"type":53},"2005-05-20",{"date":72,"type":53},"2015-06-30",{"name":5,"class":6},1]