[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565139":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":16,"locations":26,"responsibleParty":64,"collaborators":66,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":10,"enrollmentInfo":79,"targetDuration":10,"studyType":82,"phases":10,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":51,"whyStopped":10,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Patients with breast cancer leptomeningeal disease (LMD)",null,"Participation involves allowing access to participant medical records including the genetic information of the tumor, undergoing standard-of-care work up as indicated (this may include MRI of brain or spine, spinal tap, etc.), providing a cerebrospinal (CSF) sample (less than 2 tablespoons), blood sample (about 4 tablespoons) at baseline and possibly again after month, and answering online questionnaires monthly.\n\nJohns Hopkins Molecular Tumor Board will review clinical and genetic information and provide treatment recommendations. CSF and blood will be collected at baseline no matter what treatment is recommended. If possible, collect CSF and blood again after one month. Additional blood and CSF sampling may also be obtained if\u002Fwhen therapy changes.\n\nThe oncologist will ultimately decide if participant will proceed with the recommend treatment or not. Health information and questionnaires are obtained to assess how participants are doing on therapy.",[13],{"name":14,"affiliation":5,"role":15},"Cesar Santa-Maria, MD","PRINCIPAL_INVESTIGATOR",[17,22],{"name":18,"role":19,"phone":20,"phoneExt":10,"email":21},"Hopkins Breast Trials","CONTACT","410-614-1361","HopkinsBreastTrials@jhmi.edu",{"name":23,"role":19,"phone":24,"phoneExt":10,"email":25},"Sidney Kimmel Cancer Center Clinical Research Office","410-955-8866","jhcccro@jhmi.edu",[27,50],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Sibley Memorial Hospital","NOT_YET_RECRUITING","Washington D.C.","District of Columbia","20016","United States","US",{"type":36,"coordinates":37},"Point",[38,39],-77.03637,38.89511,{"lat":39,"lon":38},[42,46],{"name":43,"role":19,"phone":44,"phoneExt":10,"email":45},"Azka Tariq","202-660-5712","atariq6@jhmi.edu",{"name":47,"role":19,"phone":48,"phoneExt":10,"email":49},"Aliya Lalji","202-243-2294","alalji1@jhmi.edu",{"facility":5,"status":51,"city":52,"state":53,"zip":54,"country":33,"countryCode":34,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"RECRUITING","Baltimore","Maryland","21287",{"type":36,"coordinates":56},[57,58],-76.61219,39.29038,{"lat":58,"lon":57},[61,62],{"name":18,"role":19,"phone":20,"phoneExt":10,"email":21},{"name":63,"role":15,"phone":10,"phoneExt":10,"email":10},"Cesar A Santa-Maria, M.D.",{"type":65,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[67],{"name":68,"class":6},"Avon Foundation","100565139","study-in-patients-with-breast-cancer-leptomeningeal-metastasis-100565139",false,"NCT06638294","Study in Patients With Breast Cancer Leptomeningeal Metastasis","A Translational Observational Biorepository and Management Study in Patients With Breast Cancer Leptomeningeal Metastasis: The BioLept Study","BioLept","Inclusion Criteria:\n\n* Male or female, aged 18 or older\n* History of breast cancer (any subtype)\n* Suspected breast cancer-related leptomeningeal metastasis (i.e., by clinical signs or symptoms (i.e., peri-oral dysesthesia, unexplained new neurological symptoms in the absence of brain metastasis), radiographic, or by cerebrospinal fluid analysis), whereby patient will be treated along an leptomeningeal disease paradigm.\n* Previous central nervous system metastasis (including leptomeningeal disease or brain metastasis) is eligible.\n* Eastern Cooperative Oncology Group (ECOG) score of ≤3 or Karnofsky performance status ≥60.\n\nExclusion Criteria:\n\n* Suspected central nervous system recurrence of hematologic malignancy, lymphoma or other solid tumor\n* Not eligible for treatment of leptomeningeal disease.","ALL","18 Weeks",{"count":80,"type":81},30,"ESTIMATED","OBSERVATIONAL","Traditional clinical trials in patients with breast cancer leptomeningeal disease (LMD) are challenging as patients often have a rapidly progressive course and prognosis is poor, making meeting standard eligibility difficult. Furthermore, there is limited information about the biology of LMD. The investigators thus propose a study that is as inclusive as possible, which will allow the investigators to collect biospecimens and clinical outcomes to learn more about LMD biology, but still potentially provide benefit for patients, by providing patients rapid diagnostics and multi-disciplinary treatment recommendations.",[85],"Leptomeningeal Metastasis of Breast Cancer",[87],"breast cancer","2025-11-25",{"date":90,"type":91},"2025-11-28","ACTUAL",{"date":93,"type":91},"2024-11-25",{"date":95,"type":81},"2028-12",{"name":5,"class":6},2]