Global Prospective, Observational Cohort of Adult Patients With Primary Sclerosing Cholangitis (WIND-PSC Study)
This study is looking at adults with a liver condition called Primary Sclerosing Cholangitis (PSC). It's an "observational study," meaning researchers will watch how the condition progresses in people's everyday lives, rather than giving them new treatments. They will collect information on liver health, symptoms, medicines taken, and how people feel. The goal is to build a rich picture of PSC in the real world. This information is crucial for comparing new treatments in future studies and helping scientists understand what makes a PSC treatment truly effective. It aims to improve how new medicines are tested for PSC in the future.
At a glance
What is this study about?
This study, called WIND-PSC, is all about understanding a liver condition called Primary Sclerosing Cholangitis, or PSC. It's a special type of study called an "observational study." This means that participants won't be given any new medicines or treatments as part of the study itself. Instead, researchers will simply observe and collect information about how PSC affects people in their daily lives over a period of time. Think of it like watching how a garden grows naturally, rather than adding new fertilizers or plants.
The main goal is to gather a lot of information about PSC from many adults around the world. This includes details about how their liver health changes, any new symptoms they experience, what medicines they are already taking, and how they report feeling. This detailed picture of PSC in the 'real world' is incredibly valuable. It helps scientists understand the natural course of the disease and how it progresses in different people.
Why is this important? This real-world information will be used to help design better clinical trials for new PSC treatments in the future. For example, if a new drug is being tested, researchers can compare its effects to the information gathered in this study, which acts as a 'baseline' or 'control group.' This helps them figure out if the new drug is truly making a difference. Ultimately, this study aims to speed up the development of more effective treatments for PSC by making future drug trials more efficient and informative.
Key takeaways
- This study is observing adults with PSC to understand the condition better.
- It aims to improve future clinical trials for new PSC treatments.
- Participants will not receive new medication; standard care continues.
- Information collected includes liver health, symptoms, medicines, and how participants feel.
- Data gathered is crucial for developing more effective PSC therapies.
- Participation helps advance PSC research without changing your current treatment plan.
Who may be eligible?
To join this study, you generally need to be an adult between 18 and 75 years old and have a confirmed diagnosis of large duct PSC. You must also be able to understand the study instructions and agree to participate by signing a consent form.
There are certain reasons why you might not be able to join. For instance, if you have other serious liver diseases that aren't PSC, like hepatitis or alcoholic liver disease, you likely won't be eligible. Also, if you have a different type of PSC called small-duct PSC, or if you've recently been hospitalised or have certain serious complications from your liver disease, you wouldn't qualify. Using a very high dose of a common PSC medication (UDCA) or having already had a liver transplant would also mean you can't take part.
However, it's worth noting some specific situations. If you have both PSC and an autoimmune liver condition called AIH (Autoimmune Hepatitis) overlap, or if you have some mild fatty liver unrelated to PSC, you might still be able to join. Your doctor can help determine if this study is right for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 75 years old?
- Do you have a confirmed diagnosis of large duct PSC?
- Are you able to understand study instructions and sign a consent form?
- Do you *not* have other serious liver diseases (like hepatitis or alcoholic liver disease, but PSC/AIH overlap is fine)?
- Have you *not* had a liver transplant?
- Are you *not* experiencing severe liver complications like significant fluid build-up or serious confusion?
What does participation involve?
If you decide to participate in the WIND-PSC study, you won't be given any new experimental medications. Instead, the study will involve collecting information about your health over time through your regular medical appointments.
This means that your doctors will gather details about your liver health, how you are feeling, any symptoms you experience, results from scans and blood tests, and records of the medicines you are taking. You will also be asked to complete questionnaires about your symptoms and how you are generally feeling. This information will be collected during your routine clinic visits. The total duration of your participation will depend on how long the study continues to collect data, which could be several years.
Potential risks and benefits
Locations (18)
- UC DavisVerified postcodeSacramento, United States· Recruiting
- California Pacific Medical CenterVerified postcodeSan Francisco, United States· Recruiting
- University of California, San FranciscoVerified postcodeSan Francisco, United States· Recruiting
- Yale UniversityVerified postcodeNew Haven, United States· Recruiting
- Schiff Center for Liver Diseases / University of MiamiVerified postcodeMiami, United States· Recruiting
- Indiana UniversityVerified postcodeIndianapolis, United States· Recruiting
- Massachusetts General HospitalVerified postcodeBoston, United States· Recruiting
- Beth Israel Deaconess Medical CenterVerified postcodeBoston, United States· Recruiting
- Mayo ClinicVerified postcodeRochester, United States· Recruiting
- UT Southwestern Medical CenterVerified postcodeDallas, United States· Recruiting
- Virginia Commonwealth UniversityVerified postcodeRichmond, United States· Recruiting
- University of AlbertaVerified postcodeEdmonton, Canada· Recruiting
Common questions
What is Primary Sclerosing Cholangitis (PSC)?
PSC is a long-term liver disease that damages the bile ducts, which carry digestive fluid from your liver. This can lead to liver scarring and other health problems.
Will I receive new medicine in this study?
No, this is an 'observational' study. You won't receive any new study medicines, and your doctors will continue with your usual care.
Why is this study important if it doesn't give new treatments?
The information gathered from people like you will help scientists design much better studies for future PSC medicines and understand which treatments work best.
What information will the study collect about me?
Researchers will collect details about your liver health, symptoms you notice, results from your tests and scans, and the medicines you already take, often during your regular clinic visits.
Can I leave the study at any time?
Yes, you have the right to withdraw from the study at any point, and it will not affect your regular medical care.
How to find out more
Stephen Rossi, PharmD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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