Clinical Trial Summary
The first 12 months after liver transplantation (LT) are decisive in posttransplant outcome,
as almost half of deaths and two thirds of graft loss requiring retransplant occur in the
first year after LT. Since delaying retransplantation in those patients that experience an
unfavorable posttransplant course directly impacts their outcome, timely decision making is
of paramount importance in these individuals. However, balancing the need and right timing
for retransplantation in individual patients with a complicated posttransplant course is
currently a difficult challenge that relies on imperfect clinical variables and biomarkers,
as well as the experienced judgment of the transplant team.
Building on the findings of a pilot study in liver transplant recipients (n = 131) led by the
Ghent University Hospital, we want to validate the prognostic performance of the
GlycoTransplantTest on a multicentric scale. In this pilot study, a single glycomic signature
at day 7 after LT allowed accurate prediction of graft loss at 3 months after LT. The serum
glycome of those patients experiencing graft loss was characterized by increased
undergalactosylation and an increased presence of fucosylated and triantennary glycans. After
statistical modeling, use of an optimized cutoff based on the relative abundance of 13 serum
glycans showed a strong association with graft loss at 3 months (odds ratio 70.211; P<0.001;
95% CI: 10.876-453.23).
Using sequential measurements of serum glycomics in liver transplant recipients, we want to
prospectively study and validate the predictive value of the serum glycomic signature for
graft survival and overall survival at 3-months (primary end point) and 12-months after liver
transplantation (secondary end point).
Determination of the serum glycomic profile is a high-throughput technique that allows to
study and quantify the relative abundance of sugar chains (glycans) anchored at specific
sites of serum proteins. This technique has shown a very strong prognostic value for graft
loss at 3-months after liver transplantation in a pilot study at the Ghent University
Hospital.
In this large-scale multicentric prognostic study, we will collect serum samples of liver
transplant recipients at fixed time points.
Apart from the serum glycomic profile, we will collect data from the patients electronic
record: demographic data (gender, age), data directly relevant to the indication of
transplant (eg. imaging for primary liver cancer, lab values for diagnosis of end-stage liver
disease), and outcome data (graft survival, overall survival, follow-up time). This list is
non-exhaustive.
Using this approach, we will demonstrate the predictive validity of serum glycomics in liver
transplant recipients for graft survival and overall survival at 3- and 12-months post-LT.
Building on these data, the use of a simple blood test could differentiate patients at risk
of graft loss and thus represent a paradigm shift directing these patients to timely
treatment adaptations.
