Serum Glycomics as Prognostic and Diagnostic Biomarkers of Disease Recurrence in Liver Transplant Recipients With Hepatocellular Carcinoma

NCT05866783 | Recruiting

• 1 other identifier: ONZ-2022-0492
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Prognostic Biomarker; Liver Transplantation; Diagnostic Biomarker; Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• HCC recurrence

  18 months

• Disease-free survival

  18 months

Secondary Outcomes (1)

• Overall survival

  10 years

Study Arms (2)

No HCC recurrence

Patients receiving a liver transplantation that do NOT develop HCC recurrence after liver transplantation.

Diagnostic Test: HCCRecurrencePrognosticScore; Diagnostic Test: HCCRecurrenceDiagnosticScore

HCC recurrence

Patients receiving a liver transplantation that develop HCC recurrence after liver transplantation.

Diagnostic Test: HCCRecurrencePrognosticScore; Diagnostic Test: HCCRecurrenceDiagnosticScore

Interventions

HCCRecurrencePrognosticScore DIAGNOSTIC_TEST

Determination of serum glycomics pre-transplant using an optimal cutoff based on statistic modeling

HCC recurrence; No HCC recurrence

HCCRecurrenceDiagnosticScore DIAGNOSTIC_TEST

Determination of serum glycomics post-transplant using an optimal cutoff based on statistic modeling

HCC recurrence; No HCC recurrence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with hepatocellular carcinoma active on the waiting list or undergoing a liver transplantation

You may qualify if:

• 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

You may not qualify if:

• Diagnosis of other liver tumors (eg. liver metastasis, cholangiocarcinoma)

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Hospital, Antwerp: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator
• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Xavier Verhelst, MD, PhD

CONTACT

+32 9 332 23 71; xavier.verhelst@uzgent.be

Emma Butaye

CONTACT

+32 496 88 17 91; emma.butaye@uzgent.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 19, 2023
• Study Start: April 28, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2038
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

BE (1)