Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-02-25 @ 6:42 PM
Study NCT ID:
NCT02247934
Status:
COMPLETED
Last Update Posted:
2016-02-09
First Post:
2014-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of a Patient-Reported Outcome Measure to Assess Symptoms in Patients With Primary Sclerosing Cholangitis (PSC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015209', 'term': 'Cholangitis, Sclerosing'}], 'ancestors': [{'id': 'D002761', 'term': 'Cholangitis'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-08', 'studyFirstSubmitDate': '2014-09-05', 'studyFirstSubmitQcDate': '2014-09-23', 'lastUpdatePostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'List Primary Sclerosing Cholangitis (PSC) Symptoms for inclusion in patient questionnaire', 'timeFrame': 'Up to 12 months', 'description': 'Interview participants to generate a list of the most common symptoms, as well as the most important symptoms, experienced by patients with PSC, and whether each symptom impacts day-to-day functioning.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Primary sclerosing cholangitis', 'PSC'], 'conditions': ['Primary Sclerosing Cholangitis']}, 'descriptionModule': {'briefSummary': "The objectives of this qualitative study are to elicit concepts about symptoms that are important to patients with primary sclerosing cholangitis (PSC), as well as the key impacts of symptoms on patients' day-to-day functioning.", 'detailedDescription': 'In Step I, concept elicitation one-on-one interviews (via telephone or in person) will be conducted. The aims of the concept elicitation interviews are to:\n\n1. Identify the most common symptoms, as well as the most important symptoms, for patients with PSC, and\n2. Assess whether these symptoms impact day-to-day functioning\n\nAn instrument will be developed based on the symptoms reported and in Step II of the study, the performance of the instrument will be assessed with further interviews.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be recruited from approximately 5 clinical sites based in the United States.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of PSC based on liver biopsy or diagnostic imaging, with diagnosis made at least three months prior to screening\n* Patient report of PSC symptoms associated with PSC diagnosis\n* Able to speak, read, and understand English\n* Willing and able to provide written informed consent to participate in the research study\n\nExclusion Criteria:\n\n* Patients with other causes of liver or biliary disease, including viral hepatitis, alcoholic liver disease, primary biliary cirrhosis, and secondary sclerosing cholangitis\n* Patient with history of liver cirrhosis\n* Patients with history of cholangiocarcinoma\n* Patients who have received a liver transplant\n* Patients currently enrolled in PSC clinical trials; and\n* STEP II ONLY: Enrolled in or participated in Step I of this study (concept elicitation)'}, 'identificationModule': {'nctId': 'NCT02247934', 'briefTitle': 'Development of a Patient-Reported Outcome Measure to Assess Symptoms in Patients With Primary Sclerosing Cholangitis (PSC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'Development of a Patient-Reported Outcome Measure to Assess Symptoms in Patients With Primary Sclerosing Cholangitis (PSC)', 'orgStudyIdInfo': {'id': 'A-13601-000'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Concept elicitation interviews (Step I)', 'description': 'Approximately 20 participants will be included.'}, {'label': 'Cognitive interviews (Step II)', 'description': 'Approximately 30 participants will be included.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital, Denver Health Medical Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Miller School of Medicine - Schiff Center for Liver Diseases', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '20814', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Evidera', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Organ Care Research Swedish Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Rob Myers, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}