Nctid:
NCT06617013
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000003550", "term"=>"Cystic Fibrosis"}, {"id"=>"D000005355", "term"=>"Fibrosis"}], "ancestors"=>[{"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000010182", "term"=>"Pancreatic Diseases"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}, {"id"=>"D000008171", "term"=>"Lung Diseases"}, {"id"=>"D000012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D000030342", "term"=>"Genetic Diseases, Inborn"}, {"id"=>"D000007232", "term"=>"Infant, Newborn, Diseases"}], "browseLeaves"=>[{"id"=>"M8485", "name"=>"Fibrosis", "asFound"=>"Fibrosis", "relevance"=>"HIGH"}, {"id"=>"M6755", "name"=>"Cystic Fibrosis", "asFound"=>"Cystic Fibrosis", "relevance"=>"HIGH"}, {"id"=>"M8880", "name"=>"Gastroesophageal Reflux", "relevance"=>"LOW"}, {"id"=>"M13102", "name"=>"Pancreatic Diseases", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M11168", "name"=>"Lung Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}, {"id"=>"M23686", "name"=>"Genetic Diseases, Inborn", "relevance"=>"LOW"}, {"id"=>"M10276", "name"=>"Infant, Newborn, Diseases", "relevance"=>"LOW"}, {"id"=>"T1710", "name"=>"Cystic Fibrosis", "asFound"=>"Cystic Fibrosis", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"Diseases and Abnormalities at or Before Birth", "abbrev"=>"BC16"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>20}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10-23", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-04-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-25", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-04-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Change from baseline in the mean GSAS score", "timeFrame"=>"baseline and 12 weeks", "description"=>"The Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) is a 15-item tool validated in children in assessing gastroesophageal reflux disease-related symptoms. The GSAS ranges from 0 to 490, with a higher score representing worse GERD symptoms, and a score ≥ 15 reflects significant GERD symptoms."}, {"measure"=>"Mean GSAS score in children with CF on GERD therapy", "timeFrame"=>"Baseline", "description"=>"GSAS ranges from 0 to 490, with a higher score representing worse GERD symptoms, and a score ≥ 15 reflects significant GERD symptoms. A value of 80 will be used as a maximum cut-off for mild symptoms as this was 2 SD from the mean GSAS for children without baseline GERD."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["GERD in Children", "Cystic Fibrosis in Children"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to use a survey to measure reflux symptoms in patients with Cystic Fibrosis who are on reflux treatment, and to monitor their symptoms after stopping the reflux treatment."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"17 years", "minimumAge"=>"6 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Children 6-17 years of age with a confirmed CF diagnosis by either a positive sweat test or 2 disease causing CFTR mutations.\n* GERD medications documented at visit 1\n* Stable GERD medication dose for 3 months\n* Pediatric GERD Symptom Assessment Score \\<80\n* Signed consent\n\nExclusion Criteria:\n\n* Declining to participate in the study or sign consent\n* Unwillingness to stop GERD therapy\n* History of severe GERD per gastroenterology diagnosis and documentation\n* GSAS score \\>80"}, "identificationModule"=>{"nctId"=>"NCT06617013", "briefTitle"=>"GERD in Children With Cystic Fibrosis", "organization"=>{"class"=>"OTHER", "fullName"=>"Duke University"}, "officialTitle"=>"Characteristics of Gastroesophageal Reflux in Children With Cystic Fibrosis", "orgStudyIdInfo"=>{"id"=>"PRO00115374"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Child with CF on GERD therapy without severe GERD", "description"=>"The GSAS will be completed at baseline, GERD therapy will be discontinued, and GSAS will be repeated 12 weeks later.", "interventionNames"=>["Other: Discontinuation of GERD therapy"]}], "interventions"=>[{"name"=>"Discontinuation of GERD therapy", "type"=>"OTHER", "description"=>"GERD therapy will be discontinued at time of enrollment.", "armGroupLabels"=>["Child with CF on GERD therapy without severe GERD"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"27710", "city"=>"Durham", "state"=>"North Carolina", "country"=>"United States", "contacts"=>[{"name"=>"Williams, DO", "role"=>"CONTACT", "email"=>"shannon.williams@duke.edu", "phone"=>"678-837-8156"}], "facility"=>"Duke University Hospital", "geoPoint"=>{"lat"=>35.99403, "lon"=>-78.89862}}], "centralContacts"=>[{"name"=>"Shannon P Williams, DO", "role"=>"CONTACT", "email"=>"shannon.williams@duke.edu", "phone"=>"678-837-8156"}, {"name"=>"Shatha Yousef, MD", "role"=>"CONTACT", "email"=>"shatha.yousef@duke.edu"}], "overallOfficials"=>[{"name"=>"Shatha Yousef", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Duke University Hospital"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Duke University", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Cystic Fibrosis Foundation", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
