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Dr Jesús Bañales

Metabolic based prediction of prognosis and early detection of bile duct cancer and recurrent PSC

Awarded to the Biodonostia Health Research Institute

Awardholder: Dr Jesús Bañales, Liver Diseases Group

The total grant awarded is £45,000

Duration of award: September 2019 to September 2021

Award details: Metabolic-based prediction of prognosis in patients with primary sclerosing cholangitis and early diagnosis of cholangiocarcinoma: new non-invasive strategy.

Updates on progress

How will this award help PSC patients?

This proposal will identify new accurate non-invasive diagnostic and prognostic biomarkers for the management of PSC patients.

With these new biomarkers, it will be possible to identify the patients that might be at risk for developing CCA, thus allowing a more intense monitoring of the patients and the creation of a priority list of transplantation, as well as the patients that will experience disease recurrence after liver transplantation.

Moreover, these biomarkers will allow the early diagnosis of this biliary cancer in patients with PSC.

Therefore, this project will contribute with pivotal findings that will directly and positively impact patient wellbeing and quality of life.



Primary sclerosing cholangitis (PSC) is a chronic cholestatic biliary disease of unknown aetiology, which increases the risk of developing cholangiocarcinoma (CCA) (~15%). The aggressiveness, late-diagnosis and lack of efficient therapies markedly contribute the high mortality of this cancer.

Currently, there are no available accurate non-invasive biomarkers for PSC surveillance or early diagnosis of CCA, which is warranted to monitor disease progression and to guide therapeutic strategies.

In a recent work from our group, we described the presence of specific serum metabolic biomarkers that effectively allowed the specific diagnosis of PSC, CCA and hepatocellular carcinoma (HCC) [Banales JM, et al. Hepatology 2018; in press]. Moreover, these serum metabolite biomarkers also allowed for the differential diagnosis of intrahepatic CCA vs HCC, which currently represents a major clinical challenge nowadays. In this international collaborative study, which included 139 patients (discovery and validation cohorts), we were able to expand the knowledge in this field, actively contributing with key findings in the quest for new non-invasive biomarkers for these human diseases. In this regard, this approach represents a promising new diagnostic and prognostic strategy since we have recently demonstrated the value of these types of serum metabolites to accurately and differentially diagnose non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH).

With these results, we were able to develop the first commercial serum metabolomics test to diagnose these diseases in collaboration with OWL Metabolomics.

Through this application, we propose to analyze the serum metabolomic profile of patients with PSC and investigate new biomarkers to predict prognosis (risk of CCA development and disease recurrence after liver transplantation) and to early diagnose CCA. For this purpose, we will include 5 distinct groups of patients:

  1. isolated PSC (no CCA development in the follow up);
  2. PSC patients before CCA development (CCA development in the follow up);
  3. PSC patients with concomitant CCA (PSC-CCA);
  4. PSC patients whom underwent liver transplantation (LTX) without disease recurrence;
  5. PSC patients whom underwent liver transplantation with disease recurrence.

This International Collaborative Study involves referent Centers from the International Primary Sclerosing Cholangitis Study Group (IPSCSG) and European Network for the Study of Cholangiocarcinoma (ENSCCA), which currently represent 2 pivotal collaborative networks that are actively working for the greater good of PSC patients.

In this study, more than 150 serum samples will be used, further allowing the discovery of new diagnostic and prognostic biomarkers for PSC and CCA that might be translated into clinical practice in a near future.



Three International referent Centers [Donostia University Hospital (San Sebastian, Spain), Medical University of Warsaw (Warsaw, Poland), and Oslo University Hospital (Oslo, Norway)] have already collected together serum samples (more than n=30 per group under study) from patients with:

(I) Isolated PSC (no CCA development in the follow up)

(II) PSC patients before CCA development (CCA development in the follow up)

(III) PSC patients with concomitant CCA (PSC-CCA)

(IV) PSC patients whom underwent liver transplantation without disease recurrence

(V) PSC patients whom underwent liver transplantation with disease recurrence.

The clinical value of the serum metabolomics profile of the comparatives “I vs II”, “II vs III”, “I vs IV”, “I vs V”, and “IV vs V” will be statistically assessed, and the results will be also correlated with the clinical and biochemical information of the patients.

This clinical study has been approved by the respective Ethical Committees of Clinical Experimentation from all 3 Centers (Spain, Poland and Norway).

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