[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533534":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":44,"centralContacts":49,"locations":54,"responsibleParty":71,"collaborators":73,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":34,"enrollmentInfo":87,"targetDuration":34,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":98,"overallStatus":102,"whyStopped":34,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"University of Bern","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Epirubicin","EXPERIMENTAL","Patients in that PDOs show highest response to this drug in-vitro will be treated with Epirubicin.",[13],"Drug: Epirubicin",{"label":15,"type":10,"description":16,"interventionNames":17},"Mitomycin","Patients in that PDOs show highest response to this drug in-vitro will be treated with Mitomycin.",[18],"Drug: Mitomycin",{"label":20,"type":10,"description":21,"interventionNames":22},"Gemcitabine","Patients in that PDOs show highest response to this drug in-vitro will be treated with Gemcitabine.",[23],"Drug: Gemcitabine",{"label":25,"type":10,"description":26,"interventionNames":27},"Docetaxel","Patients in that PDOs show highest response to this drug in-vitro will be treated with Docetaxel.",[28],"Drug: Docetaxel",[30,35,38,41],{"type":31,"name":9,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","In PDOs from patients that show highest response to Epirubicin, this drug will be instilled intravesically once weekly for 6 times.\n\nEpirubicin will be used as a concentrate for injection\u002Finstillation 2 mg\u002Fml in total 50mg per vial. Prior to use, the concentrate for injection is diluted with 25ml of 0.9% saline solution to obtain the final Solution with 1mg\u002Fml of Epirubicin.",[9],null,{"type":31,"name":15,"description":36,"armGroupLabels":37,"otherNames":34},"In PDOs from patients that show highest response to Mitomycin, this drug will be instilled intravesically once weekly for 6 times.\n\nMitomycin C will be used as 20mg dry powder. Prior to use, the powder will be dissolved in 50ml of 0.9% saline solution according to the manufacturer instructions",[15],{"type":31,"name":20,"description":39,"armGroupLabels":40,"otherNames":34},"In PDOs from patients that show highest response to Gemcitabine, this drug will be instilled intravesically once weekly for 6 times.\n\nGemcitabine will be used as 2000 mg\u002F50ml. For intravesical application, 1000mg of gemcitabine (corresponding to 25ml) will be diluted in 25ml 0.9% saline solution, to obtain the gemcitabine concentration of 1000mg\u002F50ml used for instillation.",[20],{"type":31,"name":25,"description":42,"armGroupLabels":43,"otherNames":34},"In PDOs from patients that show highest response to Docetaxel, this drug will be instilled intravesically once weekly for 6 times.\n\nDocetaxel will be used as 140mg\u002F7ml solution. For intravesical application, 48.825ml of saline will be added to 1.875ml Docetaxel solution (according 37.5mg of Docetaxel). The concentration of this solution is 0.74mg\u002Fml by a total volume of the instillation solution of 50,7.",[25],[45],{"name":46,"affiliation":47,"role":48},"Roland Seiler, Prof.","Spitalzentrum Biel, University of Bern","STUDY_CHAIR",[50],{"name":46,"role":51,"phone":52,"phoneExt":34,"email":53},"CONTACT","+41 32 324 32 06","urologie@szb-chb.ch",[55],{"facility":56,"status":34,"city":57,"state":34,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Roland Seiler","Biel","2501","Switzerland","CH",{"type":62,"coordinates":63},"Point",[64,65],8.21773,46.45587,{"lat":65,"lon":64},[68],{"name":46,"role":51,"phone":69,"phoneExt":34,"email":70},"+41 32 324 24 06","r_seiler@gmx.ch",{"type":72,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[74],{"name":75,"class":76},"Spitalzentrum Biel","UNKNOWN","100533534","phase-2-precise-neoadjuvant-chemoresection-of-low-grade-nmibc-100533534",false,"NCT06227065","Precise Neoadjuvant Chemoresection of Low Grade NMIBC","Precise Neoadjuvant Chemoresection of Low Grade NMIBC Guided by Drug Screens in Patient Derived Organoidst: A Single Center, Open-label, Phase II Trial","POLO","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Signed Informed Consent Form\n* ECOG performance status of 0 or 1\n* Previous history of low risk non-muscle invasive urothelial carcino-ma of the bladder with recurrent papillary tumor and negative urine cytology or Primary solitary papillary tumor, \\\u003C3cm and negative urine cytology\n\nExclusion Criteria:\n\n* Known previous high grade and\u002For intermediate or high risk non-muscle invasive bladder cancer\n* Anticoagulation other than acetylsalicylic acid\n* Previous Intravesical biological\u002Fimmuno- (BCG) therapy\n* Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol","ALL","18 Years",{"count":88,"type":89},28,"ESTIMATED","INTERVENTIONAL",[92],"PHASE2","Based on the unmet clinical need to reduce invasiveness of treatment of low grade NMIBC, the investigators conduct this prospective, open label, single arm and single center phase II trial. The investigators aim to use drug screens in PDOs to guide neoadjuvant intravesical instillation therapy with either Epirubicin, Mitomycin C, Gemcitabine or Docetaxel to achieve chemoresection NMIBC.",[95,96,97],"Bladder Cancer","Non-muscle Invasive Bladder Cancer","Low-risk",[99,100,101],"Patient derived organoids","Neoadjuvant chemoresection","Precise drug selection","NOT_YET_RECRUITING","2024-01-25",{"date":105,"type":106},"2024-01-26","ACTUAL",{"date":108,"type":89},"2024-10",{"date":110,"type":89},"2029-10",{"name":5,"class":6},1]