Professor Jesús Bañales and Dr Pedro Rodrigues
Developing a blood test to predict and detect bile duct cancer in individuals with PSC
Professor Jesús Bañales and Dr Pedro Rodrigues, Biodonostia Health Research Institute
The total grant awarded is £50,000
Duration of award: 3 years (Sep 2023 to Aug 2026)
Research title: Developing a blood test to predict and detect bile duct cancer in individuals with PSC
Research Update: Ask the Expert 10 July 2025
Summary
PSC Support has awarded £50,000 to Professor Jesús Bañales and Dr Pedro Rodrigues towards developing a blood test to detect early bile duct cancer and to predict who is most at risk in people with PSC. In a huge international collaboration, this will involve the use of machine learning and the analysis of blood from over 300 blood samples.
Although bile duct cancer is rare, it is diagnosed at a point where effective treatment is difficult. Dr Bañales’ important work could lead to the first accurate and cost-effective blood test to confidently detect bile duct cancer in people with PSC. His research will help doctors to predict those most likely to develop this cancer. This would be ground-breaking and allow for closer monitoring and give those affected the chance to have early and more effective treatment.
Background
People who have PSC are at risk of getting cancer of the bile ducts. Although the risk is small, the cancer is difficult to recognise in people with PSC because damage in the bile ducts caused by PSC looks very much like this cancer. Unfortunately, there is no single test that can accurately detect bile duct cancer in its very early stages.
In a recent pilot study, Professor Bañales’ research team has already identified a combination of promising proteins in the blood to accurately detect bile duct cancer, even in people with PSC. Now this must be internationally validated on a much bigger scale.
What will Professor Jesús Bañales and Dr Pedro Rodrigues do?
The team will analyse over 300 blood samples to evaluate the proteins identified in his pilot study. He will also investigate new markers to predict who is most at risk from developing bile duct cancer and to diagnose it. The samples will come from:
- Healthy volunteers
- People with PSC who have not developed bile duct cancer in at least a five-year period
- People with PSC who have later gone on to develop bile duct cancer
- People with both PSC and bile duct cancer
A huge international collaboration of scientists studying PSC and bile duct cancer will provide samples from volunteers in their clinics. Clinical features (such as symptoms reported by the patients) collected from all the volunteers as well as the biomarker data generated by this study will be used to build machine-learning models to enhance the predictive power of the final blood test.
Why is this study important?
Although rare, developing bile duct cancer is one of the biggest fears of people living with PSC. There is an urgent need to develop a readily available and robust test to confidently detect bile duct cancer in people with PSC and identify those at greatest risk.
If the results of Professor Bañales’ pilot study are successfully reproduced (validated) in this large-scale study, the impact for people with PSC would be life-changing. We hope that this work will lead to a new, readily available and accurate blood test that means bile duct cancer can be detected early enough to allow for effective treatment. People with PSC would be able to get on with their lives without the worry of the ‘ticking time bomb’ hanging over them.
Research updates
In the first half of this international project, we made significant progress toward developing a simple blood test to help individuals with PSC assess their risk of developing CCA and enable earlier detection. Collaborating with hospitals and research centers across the globe, we collected blood samples from PSC patients: from both those who have remained cancer-free for several years and those who eventually developed CCA.
In over 800 samples contributed by international collaborators, we measured levels of blood proteins previously identified as promising biomarkers in our earlier study.
To enhance the test’s accuracy, we also added several new candidate proteins and included a range of comparison groups, such as patients with benign biliary conditions, other liver diseases, and various hepatobiliary cancers, to ensure the test specifically detects PSC-associated CCA.
Encouragingly, these biomarkers continue to differentiate between individuals at higher risk and those with early-stage cancer, even within this larger and more diverse cohort. In parallel, we are collecting clinical data, including the widely used tumour marker CA19-9, to benchmark our protein panel and integrate it into combined models. This ensures that our approach not only outperforms CA19-9 alone but also aligns with clinical realities and remains robust across different healthcare settings.
Feedback from clinicians and patient advocates, gathered at major liver disease conferences, has been overwhelmingly positive. Many have emphasised the value of a reliable, easy-to-use blood test to support surveillance and enable earlier cancer diagnosis, when treatment is most likely to be effective.
In the second half of the project, we will complete detailed statistical analyses, develop a user-friendly online tool for clinicians, and prepare our findings for publication.
Our long-term goal is to translate these discoveries into a practical, cost-effective blood test that can be deployed globally empowering PSC patients and their physicians with better tools to monitor cancer risk and detect CCA when it is most treatable.
Dr Pedro Rodrigues and Profesor Jesús Bañales, June 2025
"During the 1st year of this research proposal, we have been dedicated to the Inclusion of biological samples and creation of a database with clinical information. Currently, we are gathering one of the biggest collections of biological samples from patients with PSC from all over the world that will be used to validate the newly identified biomarkers, useful to predict bile duct cancer and diagnose it early.
"We have preliminary evaluated the levels of the candidate protein biomarkers in the serum of some patients from Latin America, validating the results observed in the European cohort. We will continue with the inclusion of samples and with the analysis of the candidate biomarkers in serum (blood)."
Professor Jesús Bañales and Dr Pedro Rodrigues. November 2024
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