NCT05926778

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2023

Completed
25 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

4 months

First QC Date

June 6, 2023

Last Update Submit

June 22, 2023

Conditions

Liver Fibrosis

Keywords

Liver FibrosisLiver TransplantationBiomarkersDNA methylation

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (2)

  • Heterogeneity of the DNA-methylation biomarkers in allograft liver fibrosis cohort

    7 Days

  • Heterogeneity of the TCR-Seq biomarkers in allograft liver fibrosis cohort

    7 Days

Study Arms (2)

Fibrosis Cohort

Adult(10 patients) and pediatric(10 patients) liver transplant recipients with fibrosis determined by histological examination of liver biopsy

Other: Liver allograft fibrosis

Control Cohort

Adult(20 patients) and pediatric(20 patients) liver transplant recipients without fibrosis determined by histological examination of liver biopsy

Interventions

Liver allograft fibrosisOTHER

Observational studies without intervention

Fibrosis Cohort

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult or pediatric recipients who underwent liver transplantation

You may qualify if:

  • 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;
  • Oral tacrolimus immunosuppressive therapy;
  • Received liver transplantation in our hospital for the first time and did not receive liver transplantation again;
  • Patients need to be admitted to hospital for programmed liver biopsy or receive liver biopsy due to abnormal liver function;
  • Complete clinical data and samples (including liver puncture biopsy specimens, plasma, and PBMC of the same period);
  • The subjects or their guardians voluntarily join the study, sign the informed consent, comply well, and cooperate with follow-up.

You may not qualify if:

  • Combined multi-organ transplantation;
  • Pregnancy or lactation;
  • Severe systemic infection;
  • Contraindications of liver biopsy with multiple organ failure or coagulation dysfunction;
  • Previous history of allergy to narcotic or sedative drugs;
  • In the stage of acute rejection hormone shock therapy;
  • Incomplete clinical data and samples;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood and liver puncture biopsy specimens

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Qiang Xia, Prof. MD

    Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU

    STUDY CHAIR

  • Hao Feng, MD., Ph.D.

    Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Feng, MD., Ph.D.

CONTACT

008615000901110surgeonfeng@live.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2023

First Posted

July 3, 2023

Study Start

July 1, 2023

Primary Completion

October 31, 2023

Study Completion

December 31, 2023

Last Updated

July 3, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)