Liver Fibrosis Clinical Trial
Official title:
Multiomics Study of Fibrosis Factors After Liver Transplantation and Exploration of Fibrosis Methylation Biomarkers
This is a retrospective observational study in liver transplantation recipients with or without allograft liver fibrosis. Based on the GM-seq and Tcr-Seq data, a novel diagnostic model including DNA-methylation and TCR-Seq biomarkers will be established.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2023 |
Est. primary completion date | October 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. Living donor liver transplantation of left outer lobe or left half liver for biliary atresia in children (=18 years old), or orthotopic liver transplantation for hepatitis B cirrhosis in adults (> 18 years old), regardless of gender; 2. Oral tacrolimus immunosuppressive therapy; 3. Received liver transplantation in our hospital for the first time and did not receive liver transplantation again; 4. Patients need to be admitted to hospital for programmed liver biopsy or receive liver biopsy due to abnormal liver function; 5. Complete clinical data and samples (including liver puncture biopsy specimens, plasma, and PBMC of the same period); 6. The subjects or their guardians voluntarily join the study, sign the informed consent, comply well, and cooperate with follow-up. Exclusion Criteria: 1. Combined multi-organ transplantation; 2. Pregnancy or lactation; 3. Severe systemic infection; 4. Contraindications of liver biopsy with multiple organ failure or coagulation dysfunction; 5. Previous history of allergy to narcotic or sedative drugs; 6. In the stage of acute rejection hormone shock therapy; 7. Incomplete clinical data and samples; 8. Situations considered unsuitable for inclusion by other researchers. |
Country | Name | City | State |
---|---|---|---|
China | Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
RenJi Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensivity | Sensivity is the true positive rate of the novel diagnostic model [Liver fibrosis is determined by histological examination of liver biopsy (LAFSc)]. | 7 Days | |
Primary | Specificity | Specificity is the true negative rate of the novel diagnostic model [Liver fibrosis is determined by histological examination of liver biopsy (LAFSc)]. | 7 Days | |
Primary | AUROC | AUROC is the area under the receiver operating characteristic curve [Liver fibrosis is determined by histological examination of liver biopsy (LAFSc)]. | 7 Days | |
Secondary | Heterogeneity of the DNA-methylation biomarkers in allograft liver fibrosis cohort | The similarities and differences of the characteristics of DNA-methylation and TCR-Seq biomarkers between children and adults in the allograft liver fibrosis cohort. | 7 Days | |
Secondary | Heterogeneity of the TCR-Seq biomarkers in allograft liver fibrosis cohort | The similarities and differences of the characteristics of TCR-Seq biomarkers between children and adults in the allograft liver fibrosis cohort. | 7 Days |
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