Professor Christoph Schramm and Dr Jan Philpp Weltzsch

Diagnostic Optimisation in Unclear Biliary Lesions - DOUBLE

Awarded to Professor Christoph Schramm and Dr Jan Philpp Weltzsch

The total grant awarded is £49,849

Duration of award: 2 years 01 Mar 2025 to 28 Feb 2027

Research title: Diagnostic Optimisation in Unclear Biliary Lesions - DOUBLE

_Professor Christoph Schramm left, Dr Jan Philipp Weltzsch right

Summary

PSC Support has awarded £49,849 to Professor Christoph Schramm and Jan Philipp Weltzsch from the University Medical Centre Hamburg-Eppendorf (UKE) in Germany.

Although bile duct cancer is rare, it is often diagnosed at a point where effective treatment is difficult. In this project, the team will assess and compare tests for diagnosing bile duct cancer to determine the best one (or combination) to diagnose this cancer early and without doubt.

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 spot because the bile duct damage caused by bile duct cancer mimics that caused by PSC. Unfortunately, there is no single test that can accurately detect bile duct cancer in its very early stages but this is very much needed for the best chance of effective treatment. Furthermore, the tests that are available tend to be invasive and often inconclusive.

The good news is that promising new tests are on the horizon, such as ones developed through Dr Bañales’ research. However, before they can be used in everyday care, we need adequate evidence from robust research studies to validate these new findings and prove their usefulness in the real world compared to existing tests.

Professor Schramm and Dr Weltzsch are conducting such a study to evaluate traditional and emerging biological markers/ tests for bile duct cancer. They will produce important evidence to support a proposal for the use of the best ways to detect bile duct cancer in PSC.

What will Professor Christoph Schramm and Dr Jan Philpp Weltzsch do?

They are looking at information from:

health records
blood samples
biliary brushings (tissue samples of the bile duct)
bile samples
urine samples

They will analyse them using established/traditional methods (such as conventional tumour markers or simple microscopy of tissue samples) and new, less established methods such as proteomics (the analysis of the entire sets of proteins in blood and urine samples) or genetic analyses of tissue samples.

They will then evaluate and compare each method to determine the most informative and accurate combination to detect early signs of bile duct cancer.

Why is this study important?

Bile duct cancer is one of the biggest fears of people living with PSC, even though it is rare. Current tests to detect it early are not conclusive, take time, and can be invasive, bringing with them the risk of more complications.

New and emerging tests seem to be able to detect bile duct cancer early, before any symptoms show. People with PSC want effective, non-invasive bile duct cancer screening. Professor Schramm and Dr Weltzsch’s work to establish the best test or combination of tests is important because it will provide the evidence needed to support the use of the right cancer screening for people with PSC.

The right screening would allow cancers to be picked up early enough for the best chance of effective treatments, reduce the need for invasive procedures and give a little more peace of mind to people with PSC.

Learn about the research team

The research team comprises of several members from various departments at the University Medical Centre in Hamburg as well as collaborative partners in Germany and abroad:

Prof. Dr. med. Christoph Schramm - Principal Investigator, MD
Medical Director of the YAEL Centre for Autoimmune Liver and Biliary Diseases, and the Martin Zeitz Centre for Rare Diseases, Senior Consultant in Internal Medicine and Gastroenterology, I. Department of Medicine, University Medical Centre Hamburg-Eppendorf.

Christoph Schramm has held an endowed professorship for rare diseases since 2015 and is head of the Martin Zeitz Centre for Rare Diseases at the UKE. He has long-standing clinical and scientific expertise regarding autoimmune liver diseases, including the investigation of mechanisms of immune regulation in the liver.

From 2015-2017, he co-coordinated the first German practice guideline on autoimmune liver diseases and contributed to the European guidelines on endoscopy in PSC, on primary biliary cholangitis (PBC), as well as to the new European practice guideline on sclerosing cholangitis. Christoph Schramm leads the YAEL Centre for Autoimmune Liver Diseases at the I. Department of Medicine, UKE, one of the leading centres for autoimmune liver diseases worldwide, where over 2,500 people with autoimmune and other immune-mediated liver and bile duct diseases are being treated. He was a founding member of the International PSC Study Group (IPSCSG) in 2010, a group which has greatly contributed to deciphering the genetic associations of PSC, and PSC-associated bile duct cancer. He was elected secretary of the International PSC Study Group (IPSCSG) from 2023-2027.

As a clinician scientist, Schramm is contributing his expertise in translational immunology and hepatology with a focus on PSC and his leadership experience to the group. He is a member of the management board of the European Reference Network for Hepatological Diseases (ERN RARE-LIVER), and within this network leads the multicentre prospective registry (R-LIVER), which has already acquired data from over 1.900 incident cases with autoimmune liver diseases. As the principal investigator of DOUBLE, Prof. Schramm played a main role in the conceptualisation of the ongoing study and was able to establish international collaborations for the analysis of the specimens obtained as part of the study. Additionally, as an experienced clinician scientist and researcher, he is involved in the experimental design and the evaluation of clinical data.

Dr. med. Jan Philipp Weltzsch - Co-Principal Investigator, MD
Resident Physician, Clinician Scientist in Gastroenterology and Hepatology YAEL outpatient centre for autoimmune liver and biliary disease I. Department of Medicine, University Medical Centre Hamburg-Eppendorf

Dr. Weltzsch is a resident in his 4th year of specialist training in internal medicine with a focus on hepatology and gastroenterology and has worked with patients with autoimmune liver and biliary disease since the beginning of his training. His clinical and research foci include clinical and translational research in autoimmune liver disease, especially PSC and autoimmune hepatitis (AIH). Dr. Weltzsch is part of the clinical trial centre at the I. Department of Medicine at the UKE and has participated in clinical and translational research on hepatocellular and cholangiocarcinoma, viral hepatitis, as well as on PSC, AIH and PBC. He was recently awarded a Clinical Research Fellowship Grant by the German Liver Foundation.

Dr. Weltzsch serves as Co-Principal Investigator for the DOUBLE trial. He has been actively involved in the planning and execution of the study since its inception. His responsibilities include screening potential study participants, enrolment of potential study participants, collecting clinical data and samples, as well as planning and conducting the experimental component of the study of the trial.

Dr. med. Jenny Krause - Advisory Investigator, MD
Resident Physician, Clinician Scientist in Gastroenterology and Hepatology I. Department of Medicine, University Medical Centre Hamburg-Eppendorf

Zehra Oguz-Coeloglu
Study Coordinator and Study Nurse I. Department of Medicine, University Medical Centre Hamburg-Eppendorf

Associated team members at the University Medical Centre Hamburg-Eppendorf

PD Dr. med. Hanno Ehlken
PD Dr. med. Andreas Lübke and PD Dr. med. Andrea Hinsch
Christian Casar, M. Sc.

Collaborative Partners and Institutions

Prof. Dr. Jesús M. Bañales, FAASLD
Mosaiques Diagnostics and Therapeutics AG