Nctid:
NCT06234384
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000012507", "term"=>"Sarcoidosis"}], "ancestors"=>[{"id"=>"D000008232", "term"=>"Lymphoproliferative Disorders"}, {"id"=>"D000008206", "term"=>"Lymphatic Diseases"}, {"id"=>"D000006968", "term"=>"Hypersensitivity, Delayed"}, {"id"=>"D000006967", "term"=>"Hypersensitivity"}, {"id"=>"D000007154", "term"=>"Immune System Diseases"}], "browseLeaves"=>[{"id"=>"M15325", "name"=>"Sarcoidosis", "asFound"=>"Sarcoidosis", "relevance"=>"HIGH"}, {"id"=>"M11225", "name"=>"Lymphoproliferative Disorders", "relevance"=>"LOW"}, {"id"=>"M11203", "name"=>"Lymphatic Diseases", "relevance"=>"LOW"}, {"id"=>"M10018", "name"=>"Hypersensitivity", "relevance"=>"LOW"}, {"id"=>"M10019", "name"=>"Hypersensitivity, Delayed", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"OTHER"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>6647}, "targetDuration"=>"1 Year", "patientRegistry"=>true}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2013-07", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2033-07", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-29", "studyFirstSubmitDate"=>"2024-01-16", "studyFirstSubmitQcDate"=>"2024-01-29", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2033-06", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Completed participation in baseline survey", "timeFrame"=>"If a survey question is completely blank, a query can be sent to request the subject to complete the section. Subjects will be contacted only twice to attempt to resolve an issue. The timeframe from time to event outcome shall not exceed 6 months.", "description"=>"Baseline survey completion"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Sarcoidosis"]}, "descriptionModule"=>{"briefSummary"=>"The goal of the study is to create a longitudinal study of patient reported outcomes for people living with sarcoidosis that maintains privacy. Patients report on the following: demographics, disease symptoms, diagnostic journey, provider experience, disease treatment, and burden of disease. The goal is to create a natural history of sarcoidosis, support research, and better understand the needs of the sarcoidosis community.", "detailedDescription"=>"Participants review a document, Understanding Your Participation, and check boxes on the Participant Informed Consent document that confirms they understand the risks/benefits of participation (or Assent if the patient is a minor age 7-18), they create an online account, and then are asked to complete the baseline survey questionnaire. Participants confirm they understand that their participation is completely voluntary, that their identifying information will be secured and encrypted, their private health information will be stored separately in a secure database. Their private information will never be shared with other people, unless its required by law. The registry may share de-identified information with researchers and other databases. Their personal information will be protected and not shared. They may choose to stop their participation at any time by contacting FSR. They are not required to fill out all the questions and can leave any unanswered. They will be contacted by the registry once a year to update or correct their health information. They can choose to be contacted by FSR if a study becomes available that they may wish to know more about."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"7 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Any adult or child (with a parent or legal guardian's assent) who has been given the diagnosis of sarcoidosis (including juvenile sarcoidosis or Blau Syndrome), and who are able to understand the consent form explaining the risks and benefits of participation.", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. English speaking\n2. Consent\n3. Sarcoidosi diagnosis -\n\nExclusion Criteria:\n\nNONE"}, "identificationModule"=>{"nctId"=>"NCT06234384", "briefTitle"=>"Foundation for Sarcoidosis Research Advanced Cures Registry (FSR-SARC Registry)", "organization"=>{"class"=>"OTHER", "fullName"=>"Foundation for Sarcoidosis Research"}, "officialTitle"=>"Foundation for Sarcoidosis Research Advanced Cures Registry (FSR-SARC Registry)", "orgStudyIdInfo"=>{"id"=>"Pro00008556"}}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Sarcoidosis diagnosis", "type"=>"OTHER", "description"=>"Participants have been diagnosed with sarcoidosis."}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"60654", "city"=>"Chicago", "state"=>"Illinois", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Tricha Shivas, MBe", "role"=>"CONTACT", "email"=>"tricha@stopsarcoidosis.org", "phone"=>"312-241-0400"}, {"name"=>"Rebecca A Epstein, MPH", "role"=>"CONTACT", "email"=>"rebecca@stopsarcoidosis.org", "phone"=>"312-340-0500"}], "facility"=>"Foundation For Sarcoidosis Research", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}], "centralContacts"=>[{"name"=>"Leslie Serhuck, MD MA Mbioethics", "role"=>"CONTACT", "email"=>"info@stopsarcoidosis.org", "phone"=>"312-341-0500"}, {"name"=>"Tricha Shivas, MBe", "role"=>"CONTACT", "email"=>"tricha@stopsarcoidosis.org", "phone"=>"312-341-0500"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO", "description"=>"All patient data is de-identified, researchers can request access to de-identified data only."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Foundation for Sarcoidosis Research", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
