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Recruiting NCT05866796

Serum GLYcomics to Predict Graft Loss and Mortality After Liver Transplantation

Conditions: Liver Transplant Failure, Prognostic Biomarkers

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 600
Sponsor: University Hospital, Ghent

Location: Xavier Verhelst Ghent Flanders

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\

Eligibility Criteria

Inclusion Criteria: * Signed and dated patient informed consent document * Age ≥ 18 years * Ability to comply with protocol-specified evaluations and scheduled visits * Diagnosis of end-stage liver disease, primary hepatic malignancy meeting the Milan criteria for liver transplantation, or acute hepatic failure * Eligible for liver transplantation and/or active on the waiting list for liver transplantation. Individuals eligible and/or active on the waiting list for multiple organ transplantation including the liver (eg. Combined liver and kidney transplantation, or intestinal transplantation) are also eligible for inclusion. * Consulted the department of Gastroenterology and Hepatology at Ghent University Hospital Exclusion Criteria: \- Transplantation of one or more organs not including the liver

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05866796). StuddyBuddy aggregates publicly available trial information.