[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100289786":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":31,"studyPopulation":32,"armGroups":33,"interventions":43,"overallOfficials":51,"centralContacts":56,"locations":65,"responsibleParty":94,"collaborators":97,"id":100,"slug":15,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":107,"sex":108,"minAge":15,"maxAge":15,"enrollmentInfo":109,"targetDuration":15,"studyType":112,"phases":15,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":68,"whyStopped":15,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"Medizinische Hochschule Brandenburg Theodor Fontane","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":15},[9,13],{"measure":10,"description":11,"timeFrame":12},"Development and evaluation of the CFAbd-Score (initially named JenAbdomen CF-Score), a CF-specific PROM following FDA recommendations","Evaluation and validation of the CFAbd-Score based on a CF patient-reported outcome measure (PROM) that includes all relevant gastrointestinal symptoms and their impact on subjective quality of life","7 years",{"measure":14,"description":15,"timeFrame":16},"Development and evaluation of a diary for assessment and quantification of abdominal symptoms, a CF-specific PROM following FDA recommendations",null,"7",[18,21,25],{"measure":19,"description":20,"timeFrame":12},"Abdominal symptoms in cystic fibrosis and their relation to genotype, history, clinical and laboratory findings","relating CFAbd-Scores to history, clinical- and laboratory findings",{"measure":22,"description":23,"timeFrame":24},"Assessing the Relation of Ultrasound Findings and Abdominal Symptoms obtained with the CFAbd-Score in Cystic Fibrosis Patients","abdominal ultrasound","3 years",{"measure":26,"description":27,"timeFrame":12},"Effects of a new therapy with CFTR-modulator on abdominal symtoms, quantified with the CFAbd-Score","Assessing the CFAbd-Score´s sensitivity to identify and quantify changes due to effective therapeutic interventions, following FDA-guidelines for validation of a PROM",{"allocation":15,"interventionModel":15,"interventionModelDescription":15,"primaryPurpose":15,"observationalModel":29,"timePerspective":30,"maskingInfo":15},"CASE_CONTROL","PROSPECTIVE","Development of a multimodal questionnaire considering the FDA guidelines for development of a PROM, the CFAbd-Score\n\n* Evaluation of reliability of the questionnaire by examining internal consistency and construct validity\n* Evaluation of reproducibility of the questionnaire by re-testing of patients\n* Assessment of cross-generational applicability of the questionnaire by sub-scoring of age groups\n* Evaluation of the responsiveness of the score by comparison with age-matched healthy controls\n* Assessment of putative relationships of abdominal symptoms with faecal inflammatory markers\n* Assessment of applicability of the questionnaire in other CF centers\n* Transfer the CFAbd-Score to other countries and languages\n\nDevelopment and validation of a CF-specific tool for daily assessment of abdominal symptoms (patient diary), the CFAbd-day2day\n\nDevelopment and validation of a CF-specific tool for assessment of abdominal symptoms in children \\\u003C 12 years of age, the CFAbd-kid","Patients with CF of all ages",[34,39],{"label":35,"type":15,"description":36,"interventionNames":37},"Patients with CF","\\>2000 in Germany, France, Italy, Spain, Denmark, Belgium, Portugal, GB, Ireland, USA, Australia, Canada, Brazil, Argentina...",[38],"Diagnostic Test: Questionnaire Patient Reported Outcome Measure (PROM)",{"label":40,"type":15,"description":41,"interventionNames":42},"Age-matched healthy controls","\\>100 in Germany \\>100 in each of the other participating countries",[38],[44],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"DIAGNOSTIC_TEST","Questionnaire Patient Reported Outcome Measure (PROM)","non-interventional",[40,35],[50],"routine-care assessments",[52],{"name":53,"affiliation":54,"role":55},"Jochen G Mainz, Prof. MD","Medizinische Hochschule Brandenburg (MHB), University","PRINCIPAL_INVESTIGATOR",[57,61],{"name":53,"role":58,"phone":59,"phoneExt":15,"email":60},"CONTACT","+493381411803","jochen.mainz@mhb-fontane.de",{"name":62,"role":58,"phone":63,"phoneExt":15,"email":64},"Franziska Duckstein, MA","+493381411841","f.duckstein@klinikum-brandenburg.de",[66,87],{"facility":67,"status":68,"city":69,"state":15,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Klinikum Westbrandenburg","RECRUITING","Brandenburg an der Havel","14770","Germany","DE",{"type":74,"coordinates":75},"Point",[76,77],12.55,52.41667,{"lat":77,"lon":76},[80,82,83,86],{"name":81,"role":58,"phone":59,"phoneExt":15,"email":60},"Jochen G Mainz, Prof. Dr.",{"name":62,"role":58,"phone":63,"phoneExt":15,"email":64},{"name":84,"role":85,"phone":15,"phoneExt":15,"email":15},"Carlos Zagoya, PhD","SUB_INVESTIGATOR",{"name":62,"role":85,"phone":15,"phoneExt":15,"email":15},{"facility":54,"status":68,"city":69,"state":15,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":88,"geoPoint":90,"contacts":91},{"type":74,"coordinates":89},[76,77],{"lat":77,"lon":76},[92,93],{"name":81,"role":58,"phone":59,"phoneExt":15,"email":60},{"name":62,"role":58,"phone":15,"phoneExt":15,"email":64},{"type":55,"investigatorFullName":95,"investigatorTitle":96,"investigatorAffiliation":5,"oldNameTitle":15,"oldOrganization":15},"Prof. Dr. Jochen G. Mainz","Director of the Cystic Fibrosis-Center",[98],{"name":99,"class":6},"University of Jena","100289786",false,"NCT03052283","Development and Validation of a Disease Specific PROM to Assess Abdominal Involvement in Patients With CF (CFAbd-Score)","Evaluation and Validation of a New Questionnaire to Identify and Quantify Abdominal Symptoms in Patients With Cystic Fibrosis Following FDA Guidelines: the CF Abd-Score (Primarily Named JenAbdomen-CF Score)","CFAbd-Score","Inclusion Criteria:\n\nCF cohort:\n\nDiagnosis of CF determined by\n\n* a sweat chloride of \\>60 mEq\u002FL and\u002For\n* detection of 2 disease causing CFTR mutations with evidence of organ involvement.\n\nHealthy controls:\n\n* Age-matched\n\nExclusion Criteria:\n\nCF cohort:\n\n* Lacking ability to cooperate of patients \u002Ftheir families, respectively\n\nHealthy controls:\n\n* Other diseases causing abdominal symptoms (Inflammatory bowel disease (IBD), alpha 1 antitrypsin deficiency, celiac disease, food allergy, gastroenteritis, etc.)",true,"ALL",{"count":110,"type":111},2000,"ESTIMATED","OBSERVATIONAL","Development, validation and evaluation of a new multimodal questionnaire to assess and quantify the abdominal involvement in patients with the inherited life shortening multi-organ disease Cystic fibrosis.\n\nIn the stepwhise development of the patient reported outcome measures (PROM) repeadedly, CF-patients, their families as well as professionals working in different fields of CF-care will be included.",[115],"Cystic Fibrosis",[117,118,119,120,121,122,123,124,125,126,127],"Cystic fibrosis","Abdomen","Pancreas","Liver","Gut","Symptom Score","Patient reported outcome measure (PROM)","diabetes","CFTR-modulator","Tricafta","Kaftrio","2023-03-31",{"date":130,"type":131},"2023-04-04","ACTUAL",{"date":133,"type":131},"2017-01-26",{"date":135,"type":111},"2027-12-31",{"name":5,"class":6},2]