Prognostic BiomarkerGLITCANCT05866783
Serum Glycomics as Prognostic and Diagnostic Biomarkers of Disease Recurrence in Liver Transplant Recipients With Hepatocellular Carcinoma
An observational study of Prognostic Biomarker and Liver Transplantation, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prognostic Biomarker, Liver Transplantation, Diagnostic Biomarker
- What is being tested?
- HCCRecurrencePrognosticScore and HCCRecurrenceDiagnosticScore
- How many people
- 500 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Apr 2023to 1 Jan 2038
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients with hepatocellular carcinoma active on the waiting list or undergoing a liver transplantation
Who may be able to join
- 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
Who cannot join
- Diagnosis of other liver tumors (eg. liver metastasis, cholangiocarcinoma)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital
Ghent, 9000
Xavier Verhelst, MD, PhD, +32 9 332 23 71, xavier.verhelst@uzgent.be
Emma Butaye, +32 496 88 17 91, emma.butaye@uzgent.be
About this study
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
- Being tested
- HCCRecurrencePrognosticScore, HCCRecurrenceDiagnosticScore
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCCRecurrencePrognosticScoreDiagnostic test
Determination of serum glycomics pre-transplant using an optimal cutoff based on statistic modeling
HCCRecurrenceDiagnosticScoreDiagnostic test
Determination of serum glycomics post-transplant using an optimal cutoff based on statistic modeling
| Study group | Role | What they receive |
|---|---|---|
| No HCC recurrence | Patients receiving a liver transplantation that do NOT develop HCC recurrence after liver transplantation. Receives: Diagnostic Test: HCCRecurrencePrognosticScore; Diagnostic Test: HCCRecurrenceDiagnosticScore | |
| HCC recurrence | Patients receiving a liver transplantation that develop HCC recurrence after liver transplantation. Receives: Diagnostic Test: HCCRecurrencePrognosticScore; Diagnostic Test: HCCRecurrenceDiagnosticScore |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCC recurrence
Measured: 18 months
Disease-free survival
Measured: 18 months
Secondary outcomes (1)
Overall survival
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start28 Apr 2023
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prognostic BiomarkerStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Antwerp, Universitaire Ziekenhuizen KU Leuven, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866783
- Sponsor's protocol ID
- ONZ-2022-0492
- Acronym
- GLITCA
- Status last verified
- May 2024
- First submitted
- 10 May 2023
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Glycomics as Prognostic and Diagnostic Biomarkers of Disease Recurrence in Liver Transplant Recipients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05866783
- Acronym / sponsor ID
- GLITCA / ONZ-2022-0492
- Conditions
- Prognostic Biomarker, Liver Transplantation, Diagnostic Biomarker, Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Hospital, Antwerp, Universitaire Ziekenhuizen KU Leuven, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Study start
- 28 Apr 2023 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2038 (estimated)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No HCC recurrence | – | Diagnostic Test: HCCRecurrencePrognosticScore, Diagnostic Test: HCCRecurrenceDiagnosticScorePatients receiving a liver transplantation that do NOT develop HCC recurrence after liver transplantation. |
| HCC recurrence | – | Diagnostic Test: HCCRecurrencePrognosticScore, Diagnostic Test: HCCRecurrenceDiagnosticScorePatients receiving a liver transplantation that develop HCC recurrence after liver transplantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients with hepatocellular carcinoma active on the waiting list or undergoing a liver transplantation
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Diagnosis of other liver tumors (eg. liver metastasis, cholangiocarcinoma)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HCCRecurrencePrognosticScoreDetermination of serum glycomics pre-transplant using an optimal cutoff based on statistic modeling | Diagnostic test | HCC recurrence, No HCC recurrence |
| HCCRecurrenceDiagnosticScoreDetermination of serum glycomics post-transplant using an optimal cutoff based on statistic modeling | Diagnostic test | HCC recurrence, No HCC recurrence |
Primary outcome
HCC recurrence
Time frame: 18 months
Disease-free survival
Time frame: 18 months
1 secondary outcome
Overall survival
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prognostic Biomarker and Liver Transplantation, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xavier Verhelst, MD, PhD (+32 9 332 23 71, xavier.verhelst@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCC recurrence (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.