[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100370867":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":42,"studyPopulation":43,"armGroups":44,"interventions":38,"overallOfficials":51,"centralContacts":59,"locations":68,"responsibleParty":102,"collaborators":105,"id":108,"slug":38,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":109,"sex":115,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":38,"studyType":121,"phases":38,"briefSummary":112,"conditions":122,"keywords":123,"overallStatus":90,"whyStopped":38,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"University of Regensburg","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":38},[9,13],{"measure":10,"description":11,"timeFrame":12},"Disease free survival","Prospective analysis of disease free after CRS\u002FHIPEC for peritoneal carcinomatosis","Through study completion, an average of 3 years",{"measure":14,"description":15,"timeFrame":12},"Overall survival","Prospective analysis of overall survival after CRS\u002FHIPEC for peritoneal carcinomatosis",[17,21,24,27,31,34],{"measure":18,"description":19,"timeFrame":20},"Renal function (serum creatinine (mg\u002Fdl))","Screening for acute renal insufficiency by measuring serum chemistry (serum creatinine (mg\u002Fdl) before as well as during the first 7 postoperative days","Before as well as during the first 7 days postoperative",{"measure":22,"description":23,"timeFrame":20},"Renal function (urea (mg\u002Fdl))","Screening for acute renal insufficiency by measuring serum chemistry (serum urea (mg\u002Fdl) before as well as during the first 7 days postoperative",{"measure":25,"description":26,"timeFrame":20},"Renal function (urine output (ml\u002F24h))","Screening for acute renal insufficiency by measuring urine output (ml\u002F24h) before as well as during the first 7 postoperative days",{"measure":28,"description":29,"timeFrame":30},"Microbiome (Bacterial 16S ribosomal RNA gene sequences will be amplified, sequenced, and analyzed in comparison to publicly available data obtained from healthy volunteers)","Longitudinal analysis of the microbial burden within samples will be quantified with droplet digital polymerase chain reaction. Bacterial 16S ribosomal RNA gene sequences will be amplified, sequenced, and analyzed in comparison to publicly available data obtained from healthy volunteers.","Before as well as at postoperative day 2 and 7",{"measure":32,"description":33,"timeFrame":30},"Cellular immune response (Frequency of NK cell subpopulations within lymphocyte populations measured by flow cytometry)","Longitudinal analysis of cellular immune responses in blood and peritoneal tissue by flow cytometry. Measuring frequency of NK cell populations within total lymphocyte population",{"measure":35,"description":36,"timeFrame":37},"Quality of life (Questionnaire-WHOQOL-BREF)","Prospective analysis of quality of life after CRS\u002FHIPEC for peritoneal carcinomatosis. Questionnaire-WHOQOL-BRE produces a quality of life profile. It is possible to derive four domain scores. There are also two items that are examined separately: question 1 asks about an individual's overall perception of quality of life and question 2 asks about an individual's overall perception of their health. The four domain scores denote an individual's perception of quality of life in each particular domain (Physical health (Score 7-35), Psychological (Score 6-30), Social relationships (Score 3-15), Environment (Score 8-40)). Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score transformed to 4-20 or 20-100.","Before surgery and through study completion, an average of 3 years",null,{"allocation":38,"interventionModel":38,"interventionModelDescription":38,"primaryPurpose":38,"observationalModel":40,"timePerspective":41,"maskingInfo":38},"CASE_CONTROL","PROSPECTIVE","Cross-sectional and longitudinal analysis of cellular immune responses in the context of disease outcome.\n\nCross-sectional and longitudinal analysis of the microbiome in the context of disease outcome.\n\nAnalysis of renal function with respect of different HIPEC regimens\n\nIdentification of clinical surrogate parameters for outcome.","Patients with suspicious peritoneal carcinomatosis",[45,48],{"label":46,"type":38,"description":47,"interventionNames":38},"Peritoneal Carcinomatosis","Patients suffering from Peritoneal carcinomatoses from either CRC, gastric cancer or primary peritoneal malignancies",{"label":49,"type":38,"description":50,"interventionNames":38},"Control group","Patients suffering from CRC or gastric cancer without peritoneal carcinomatosis",[52,56],{"name":53,"affiliation":54,"role":55},"Matthias Hornung, MD","Dept. of Surgery, University Hospital Regensburg","STUDY_DIRECTOR",{"name":57,"affiliation":54,"role":58},"Jens M Werner, MD","PRINCIPAL_INVESTIGATOR",[60,65],{"name":57,"role":61,"phone":62,"phoneExt":63,"email":64},"CONTACT","+49941944","6801","Jens.Werner@ukr.de",{"name":66,"role":61,"phone":62,"phoneExt":63,"email":67},"Monika Diehl-Bein","Monika.Diehl-Bein@klinik.uni-regensburg.de",[69,88],{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Krankenhaus der Barmherzigen Brüder Regensburg","NOT_YET_RECRUITING","Regensburg","Bavaria","93049","Germany","DE",{"type":78,"coordinates":79},"Point",[80,81],12.10161,49.01513,{"lat":81,"lon":80},[84],{"name":85,"role":61,"phone":86,"phoneExt":38,"email":87},"Pompiliu Piso, MD","+49 941 3692201","pompiliu.piso@barmherzige-regensburg.de",{"facility":89,"status":90,"city":72,"state":38,"zip":91,"country":75,"countryCode":76,"cosmosGeoPoint":92,"geoPoint":94,"contacts":95},"University Hospital Regensburg","RECRUITING","93053",{"type":78,"coordinates":93},[80,81],{"lat":81,"lon":80},[96,99],{"name":53,"role":61,"phone":97,"phoneExt":38,"email":98},"+49 941 944 6832","matthias.hornung@ukr.de",{"name":57,"role":61,"phone":100,"phoneExt":38,"email":101},"+49 941 944 6944","jens.werner@ukr.de",{"type":58,"investigatorFullName":103,"investigatorTitle":104,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"Hans J Schlitt, Prof. MD","Head of Surgery",[106],{"name":107,"class":6},"Krankenhaus Barmherzige Brüder, Regensburg","100370867",false,"NCT04108936","Longitudinal Study of CRS\u002FHIPEC for Peritoneal Carcinomatoses","Longitudinal Study of the Effect of Cytoreductive Surgery and HIPEC in Patients With Peritoneal Carcinomatoses","CRS\u002FHIPEC","Inclusion Criteria:\n\n* suspicious peritoneal carcinomatosis\n\nExclusion Criteria:\n\n* \\\u003C18 years","ALL","18 Years","80 Years",{"count":119,"type":120},250,"ESTIMATED","OBSERVATIONAL",[46],[124,125,126,127],"CRS","HIPEC","cellular immune response","microbiomes","2022-08-19",{"date":130,"type":131},"2022-08-23","ACTUAL",{"date":133,"type":38},"2016-10",{"date":135,"type":120},"2028-07",{"name":5,"class":6},2]