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Trial Title:
Serum Glycomics as Prognostic and Diagnostic Biomarkers of Disease Recurrence in Liver Transplant Recipients With Hepatocellular Carcinoma
NCT ID:
NCT05866783
Condition:
Prognostic Biomarker
Liver Transplantation
Diagnostic Biomarker
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Recurrence
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
HCCRecurrencePrognosticScore
Description:
Determination of serum glycomics pre-transplant using an optimal cutoff based on
statistic modeling
Arm group label:
HCC recurrence
Arm group label:
No HCC recurrence
Intervention type:
Diagnostic Test
Intervention name:
HCCRecurrenceDiagnosticScore
Description:
Determination of serum glycomics post-transplant using an optimal cutoff based on
statistic modeling
Arm group label:
HCC recurrence
Arm group label:
No HCC recurrence
Summary:
Liver transplantation (LT) is the only curative option for a selection of patients with
hepatocellular carcinoma (HCC) based on clinical selection criteria known as the Milan
criteria. Nevertheless, 15% of these patients still show tumour recurrence after LT. In a
monocentric pilot study, we have demonstrated that specific changes in N-glycan profiles
(measured before LT) occur in HCC patients receiving LT1. These specific changes proved
to be strongly associated with the risk of HCC recurrence and overall death after LT,
independent of the criteria used for stringent patient selection. Pathophysiologically,
it is known that abberations in protein glycosylation are involved in the onset en
development of HCC. As such, a prognostic biomarker was developed that can clearly
differentiate between patients with and without increased risk of HCC recurrence.
The primary goal of this research study is to set up a prospective, multicentre study in
order to validate the prognostic value of this glycomics-based serum biomarker. As such,
the risk of tumour recurrence in patients undergoing LT for HCC will be estimated
independent from the Milan criteria and the French alpha-fetoprotein model as the current
standard. The secondary goal is to explore the potential of serum glycomics as markers of
early recurrence after LT for HCC. More specifically, we aim to investigate whether
serial glycomics determination at fixed time points after LT could allow early detection
of recurrent HCC even before it is visible on conventional imaging. Consequently, a
diagnostic biomarker for monitoring early recurrence after LT could be developed with the
potential of redirecting treatment strategies already in an early disease stage.
In case the promising data from the pilot study will be confirmed, the prognostic
biomarker could be implemented in daily clinical practice leading to optimization of
patient selection using a simple blood test before LT. More specifically, this marker
could improve organ allocation thus preventing unnessecary treatment toxicity for the
patient and reducing the costs of treatment for society. Moreover, it should be
emphasized that a patent application was already submitted and accepted in collaboration
with TechTranfer of Ghent University (PCT/EP2021/057788-Prognostic markers of disease
recurrence in liver transplant recipients with hepatocellular carcinoma).
Criteria for eligibility:
Study pop:
Adult patients with hepatocellular carcinoma active on the waiting list or undergoing a
liver transplantation
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Signed and dated patient informed consent document
- Diagnosis of hepatocellular carcinoma
- Age ≥ 18 years
- Ability to comply with protocol-specified evaluations and scheduled visits
- Eligible for liver transplantation and/or active on the waiting list for liver
transplantation
- Consulted the department of Gastroenterology and Hepatology
Exclusion Criteria:
- Diagnosis of other liver tumors (eg. liver metastasis, cholangiocarcinoma)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Ghent University Hospital
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Xavier Verhelst, MD, PhD
Phone:
+32 9 332 23 71
Email:
xavier.verhelst@uzgent.be
Contact backup:
Last name:
Emma Butaye
Phone:
+32 496 88 17 91
Email:
emma.butaye@uzgent.be
Start date:
April 28, 2023
Completion date:
January 1, 2038
Lead sponsor:
Agency:
University Hospital, Ghent
Agency class:
Other
Collaborator:
Agency:
University Hospital, Antwerp
Agency class:
Other
Collaborator:
Agency:
Universitaire Ziekenhuizen KU Leuven
Agency class:
Other
Collaborator:
Agency:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Agency class:
Other
Source:
University Hospital, Ghent
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05866783
