Unraveling the Mechanisms Underlying Primary Sclerosing Cholangitis Through a Multidisciplinary, … (NCT04685200) | Clinical Trial Compass
RecruitingNot Applicable
Unraveling the Mechanisms Underlying Primary Sclerosing Cholangitis Through a Multidisciplinary, Integrative Research Approach
United States143 participantsStarted 2023-03-31
Plain-language summary
Background:
Primary sclerosing cholangitis is a rare chronic liver disease. It affects the bile ducts of the
liver. It can result in bile duct infections, cirrhosis, cancer, and end stage liver disease. Researchers want to learn more about this disease.
Objective:
To understand the biological causes of primary sclerosing cholangitis.
Eligibility:
Adults age 18 and older who have primary sclerosing cholangitis.
Design:
Participants will be screened with a medical history, physical exam, and blood tests.
Participants will give blood, saliva, urine, and stool samples. They will have nasal swabs. They will complete surveys.
Participants will get an intravenous (IV) catheter. A plastic tube is inserted into an arm vein.
Participants will have a colonoscopy. A tube with a video camera at the end is inserted into the rectum.
Participants will have an upper endoscopy. A scope with a light and camera at its tip is used to look inside the upper digestive tract.
Participants will have a liver biopsy, entering through the chest wall or a neck vein. Blood is drawn from a blood vessel that carries blood to the liver. A liver tissue sample is taken.
Participants will have magnetic resonance imaging or spectroscopy. They will get a contrast agent through an IV.
Participants may have an optional bone marrow aspiration. A large needle is inserted into the hip to withdraw marrow.
Participants will have a liver ultrasound.
Participants will complete a 3-day food diary. They will have a nutrition assessment.
Participants may give contact details for people who live with them, to also take part in this study.
Participation will last for 12 months.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Stated willingness to comply with all study procedures and availability for the duration of the study
. Male or nonpregnant female, greater than or equal to 18 years of age
. Evidence of PSC established by biochemical testing and either MRCP or ERCP. Participant must have evidence of large duct disease on imaging.
. Agreement to adhere to Lifestyle Considerations throughout study duration.
Exclusion criteria
. Pregnant or lactating women or females of child-bearing age not taking measures to prevent pregnancy during the period of study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The ultimate goal of this study is to generate understanding of how factors driving pathogenesis in PSC interact by capturing and integrating collated datasets from across relevant biologic systems and interpreting those in the context of phenot...
Timeframe: End of Study
Trial details
NCT IDNCT04685200
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
. History of clinical, serologic, or histopathologic evidence supporting etiologies of chronic liver disease other than PSC
. History of liver transplantation
. Diagnosis consistent with secondary sclerosing cholangitis (cholelithiasis, bile duct strictures secondary to ischemia, HIV cholangiopathy, etc.).
. Current or past clinical evidence of decompensated liver disease (e.g. ascites, bleeding esophageal varices, spontaneous bacterial peritonitis, encephalopathy, etc.).
. History of liver or bile duct lesions concerning for malignancy.
. Ca-19-9 \>130 U/microL
. Alpha-fetoprotein level greater than 200 ng/microL.