Surveillance Study for Early Detection of Cholangiocarcinoma (CCA) in Primary Sclerosing Cholangi… (NCT03041662) | Clinical Trial Compass
CompletedNot Applicable
Surveillance Study for Early Detection of Cholangiocarcinoma (CCA) in Primary Sclerosing Cholangitis (PSC)
Sweden620 participantsStarted 2011-10-31
Plain-language summary
This observational study of a national cohort of 600 Swedish PSC patients include yearly MR/MRCP, biobanking of serum, plasma and blood, followup clinical data (interventions, symptoms, labs, colonoscopy). The aim is to collect a well characterized cohort of PSC patients and provide future possibilities to evaluate biomarkers for prognosis and early cancer detection.
Who can participate
Age range
18 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:
* Diagnosis of PSC by MR/MRCP
* Life expectancy \>1 year
* Informed consent
Exclusion Criteria:
* Liver transplantation or on the waiting list
* Secondry SC
* Diagnosis of CCA
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.
1This study tracked people with PSC specifically to catch cholangiocarcinoma early — since it's now completed, has the data from this surveillance program changed what tests or how often you'd want to monitor me for bile duct cancer?
2The trial was measuring not just cholangiocarcinoma diagnosis but also liver transplantation and death as outcomes — what does that tell us about how serious the risk of CCA is for someone in my situation with PSC, and how does that affect my care plan?
3Since this was a surveillance study rather than a treatment trial, is there a standard-of-care monitoring protocol you'd recommend for me now, and does it reflect anything learned from studies like this one?
4Given that this trial focused on early detection, what are the actual screening tools — like MRI, blood markers, or endoscopy — that you would use to watch for cholangiocarcinoma in me, and how reliably do they catch it at an early stage?
5If early cholangiocarcinoma were detected through surveillance, what would my treatment options realistically look like — and would I potentially need to consider liver transplantation as part of that path?
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.