Single-Cell and Spatial Transcriptomics Analysis of Steatotic Donor Liver Susceptibility to Post-… (NCT07362745) | Clinical Trial Compass
CompletedNot Applicable
Single-Cell and Spatial Transcriptomics Analysis of Steatotic Donor Liver Susceptibility to Post-Transplant Injury
China300 participantsStarted 2015-01-01
Plain-language summary
The goal of this observational study is to understand why liver transplants from donors with fatty liver disease (steatotic donor livers) are more vulnerable to post-transplant injury, analyzing historical clinical data and collected tissue samples using advanced genetic techniques.
The main questions it aims to answer are:
* Which specific cell types and their spatial interactions contribute to increased post-transplant injury susceptibility in steatotic donor livers?
* What are the key molecular differences in gene expression between steatotic and normal donor livers following transplantation?
Researchers will compare 300 historical liver transplant cases from 2015-2025, including 50 cases with archived tissue samples available for molecular analysis, and 250 cases with clinical data only. Donor liver steatosis was assessed by histopathology when tissue was available, or by donor clinical data when tissue was not available. The two groups (steatotic donor liver recipients vs. normal donor liver recipients) will be matched based on donor age, ischemia time, recipient scores, and other key clinical parameters to control for potential confounding variables.
This is a retrospective analysis of existing data and archived biospecimens; no prospective participant enrollment or additional sample collection will occur.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Recipient Criteria:
* Participant (or legal representative if unable to read/sign) provides written informed consent
* Age 18-80 years (inclusive) at time of enrollment
* Clinical diagnosis of liver failure requiring liver transplantation
* Stable vital signs and deemed medically fit to tolerate liver transplantation surgery
Donor Criteria:
* Fatty degeneration range: Macrovesicular steatosis 0-30%
* Donor age: ≤60 years
* Cold ischemia time (CIT): ≤12 hours for deceased donors
* Liver function: ALT/AST \<5 times upper limit of normal
Exclusion Criteria:
Recipient Criteria:
* Pregnant or lactating women
* Prior history of non-autologous (allogeneic) bone marrow or stem cell transplantation
* Blood transfusion within 7 days prior to tissue sampling
* Radical cancer treatment within 3 years prior to enrollment
* Use of anti-tumor medications within 30 days prior to enrollment
* Known bleeding diathesis or coagulation disorder
* Active autoimmune disease
* Concurrent malignancy or multiple primary tumors
Donor Criteria:
* Fibrosis: Any degree of hepatic fibrosis
* Steatohepatitis: Presence of lobular inflammation or hepatocyte ballooning
* Active infection: HBV, HCV, or HIV positive
* Severe fatty liver-related comorbidities: Uncontrolled diabetes (HbA1c\>8%), severe hyperlipidemia
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Differential Expression of Post-Transplant Injury-Related Genes
Timeframe: Tissue collection at two intraoperative time points (during graft preparation and before abdominal closure); sequencing and data analysis completed within 1 year of data collection
2
Postoperative Liver Function Recovery and Clinical Outcomes
Timeframe: Up to 10 years post-transplantation, determined by retrospective data availability