Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-30 @ 12:13 AM
Study NCT ID:
NCT04342403
Status:
UNKNOWN
Last Update Posted:
2020-04-13
First Post:
2020-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Reported Outcome Instruments in Sarcoidosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012507', 'term': 'Sarcoidosis'}], 'ancestors': [{'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006968', 'term': 'Hypersensitivity, Delayed'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012129', 'term': 'Respiratory Function Tests'}], 'ancestors': [{'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-08', 'studyFirstSubmitDate': '2020-04-08', 'studyFirstSubmitQcDate': '2020-04-08', 'lastUpdatePostDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'KSQ', 'timeFrame': '6 months', 'description': 'Change in KSQ'}], 'secondaryOutcomes': [{'measure': 'SAT', 'timeFrame': '6 Months', 'description': 'Change in SAT'}, {'measure': 'Visual Analog Scale (VAS)', 'timeFrame': '6 Months', 'description': 'Change in VAS'}, {'measure': 'Forced Vital Capacity (FVC)', 'timeFrame': '6 months', 'description': 'Change in FVC percent predicted'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sarcoidosis']}, 'referencesModule': {'references': [{'pmid': '35358810', 'type': 'DERIVED', 'citation': 'Judson MA, Yucel R, Preston S, Chen ES, Culver DA, Hamzeh N, Lower EE, Sweiss NJ, Valeyre D, Veltkamp M, Victorson DE, Beaumont JL, Singh N, Shivas T, Vancavage R, Baughman RP. The association of baseline sarcoidosis measurements with 6-month outcomes that are of interest to patients: Results from the On-line Sarcoidosis Assessment Platform Study (OSAP). Respir Med. 2022 May;196:106819. doi: 10.1016/j.rmed.2022.106819. Epub 2022 Mar 18.'}]}, 'descriptionModule': {'briefSummary': 'Evaluate change of quality of life of sarcoiodosis patients over a six months using various quality of life instruments including a monthly smart phone app.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients followed at sarcoidosis clinics across United States', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of sarcoidosis by established criteria.\n* Patient has completed pulmonary function tests (spirometry) as per standard of care at the enrollment visit.\n* Ability to understand and read English at least at a 7th grade level.\n* Have access to a computer, iPad, smart phone, or another electronic device that will support the on-line sarcoidosis assessment platform.\n* The subject is willing to wear a daily activity and sleep tracker wristband (Fitbit ™ wristband) for 6 months.\n\nExclusion Criteria:\n\n• Life expectancy of \\< 1 year.'}, 'identificationModule': {'nctId': 'NCT04342403', 'acronym': 'OSAP-PRO', 'briefTitle': 'Patient Reported Outcome Instruments in Sarcoidosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Cincinnati'}, 'officialTitle': 'Clinical Studies Network Research Trial: Development of an On-Line Sarcoidosis Assessment Platform (OSAP) to Validate Sarcoidosis Phenotypes and Monitor Disease Burden Longitudinally', 'orgStudyIdInfo': {'id': '2015-7046'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sarcoidosis', 'description': 'Patients with sarcoidosis willing to participate', 'interventionNames': ['Diagnostic Test: Quality of Life']}], 'interventions': [{'name': 'Quality of Life', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Pulmonary function testing'], 'description': "Quality of life instruments including King's Sarcoidosis Questionnaire (KSQ) and Sarcoidosis Assessment Tool (SAT)", 'armGroupLabels': ['Sarcoidosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12208', 'city': 'Albany', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marc Judson, MD', 'role': 'CONTACT', 'email': 'JudsonM@amc.edu', 'phone': '518-262-5196'}], 'facility': 'Albany Medical Center', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Robert P Baughman, MD', 'role': 'CONTACT', 'email': 'bob.baughman@uc.edu', 'phone': '513-584-5225'}, {'name': 'Elyse E Lower', 'role': 'CONTACT', 'email': 'ELower@ucmail.uc.edu', 'phone': '513-584-3829'}], 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dan Culver', 'role': 'CONTACT', 'email': 'CULVERD@ccf.org', 'phone': '216-444-2200'}, {'name': 'Dan Culver', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'none at this time'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cincinnati', 'class': 'OTHER'}, 'collaborators': [{'name': 'Foundation for Sarcoidosis Research', 'class': 'OTHER'}, {'name': 'Albany Medical College', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Robert P Baughman', 'investigatorAffiliation': 'University of Cincinnati'}}}}