Development of a Patient-Reported Outcome Measure to Assess Symptoms in Patients With Primary Sclerosing Cholangitis (PSC)
1 other identifier
observational
26
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2014
Shorter than P25 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2014
CompletedFirst Posted
Study publicly available on registry
September 25, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedFebruary 9, 2016
February 1, 2016
1 year
September 5, 2014
February 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
List Primary Sclerosing Cholangitis (PSC) Symptoms for inclusion in patient questionnaire
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.
Up to 12 months
Study Arms (2)
Concept elicitation interviews (Step I)
Approximately 20 participants will be included.
Cognitive interviews (Step II)
Approximately 30 participants will be included.
Eligibility Criteria
Participants will be recruited from approximately 5 clinical sites based in the United States.
You may qualify if:
- Confirmed diagnosis of PSC based on liver biopsy or diagnostic imaging, with diagnosis made at least three months prior to screening
- Patient report of PSC symptoms associated with PSC diagnosis
- Able to speak, read, and understand English
- Willing and able to provide written informed consent to participate in the research study
You may not qualify if:
- Patients with other causes of liver or biliary disease, including viral hepatitis, alcoholic liver disease, primary biliary cirrhosis, and secondary sclerosing cholangitis
- Patient with history of liver cirrhosis
- Patients with history of cholangiocarcinoma
- Patients who have received a liver transplant
- Patients currently enrolled in PSC clinical trials; and
- STEP II ONLY: Enrolled in or participated in Step I of this study (concept elicitation)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (5)
University of Colorado Hospital, Denver Health Medical Center
Aurora, Colorado, 80045, United States
University of Miami Miller School of Medicine - Schiff Center for Liver Diseases
Miami, Florida, 33136, United States
Evidera
Bethesda, Maryland, 20814, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Organ Care Research Swedish Medical Center
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rob Myers, MD
Gilead Sciences
Study Design
- Study Type
- observational
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2014
First Posted
September 25, 2014
Study Start
October 1, 2014
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
February 9, 2016
Record last verified: 2016-02