Liver FibrosisNCT05926778
Multiomics Study of Fibrosis Factors After Liver Transplantation and Exploration of Fibrosis Methylation Biomarkers
An observational study of Liver Fibrosis, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Fibrosis
- What is being tested?
- Liver allograft fibrosis
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult or pediatric recipients who underwent liver transplantation
Who may be able to join
- 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.
Who cannot join
- 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;
- Situations considered unsuitable for inclusion by other researchers.
Trial locations and contacts
1 site in 1 country.
China1 site
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
Hao Feng, MD., Ph.D., 15000901110, surgeonfeng@live.com
About this study
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.
Read the detailed description
This is a retrospective study on 60 patients who had previously received liver transplantation in our hospital. The patients will be stratified according to age, including 20 children and 20 adults with allograft liver fibrosis after liver transplantation, while 10 children and 10 adults with fibrosis, respectively.
- The differential analysis of DNA-methylation will be performed between the allograft liver fibrosis cohort and the control cohort based on the GM-seq sequencing data. And the fibrosis-specific DNA-methylation CpG sites or regions in liver and peripheral blood will be explored in the liver transplantation recipients.
- The abundance and diversity of TCR between the allograft liver fibrosis cohort and the control cohort will be analyzed. And the fibrosis-specific TCR sequence of allograft liver fibrosis will be screened based on TCR-Seq sequencing and tNGS.
- The characteristics of DNA-methylation and TCR-Seq biomarkers in allograft liver fibrosis population will be defined. And the similarities and differences of the characteristics between children and adults will be explored.
- Based on the GM-seq and Tcr-Seq data, a novel diagnostic model including DNA-methylation and TCR-Seq biomarkers will be established.
- Conditions
- Liver Fibrosis
- Being tested
- Liver allograft fibrosis
- Keywords
- Liver Fibrosis, Liver Transplantation, Biomarkers, DNA methylation
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver allograft fibrosisOther
Observational studies without intervention
| Study group | Role | What they receive |
|---|---|---|
| Fibrosis Cohort | Adult(10 patients) and pediatric(10 patients) liver transplant recipients with fibrosis determined by histological examination of liver biopsy Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensivity
Sensivity is the true positive rate of the novel diagnostic model [Liver fibrosis is determined by histological examination of liver biopsy (LAFSc)].
Measured: 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)].
Measured: 7 Days
AUROC
AUROC is the area under the receiver operating characteristic curve [Liver fibrosis is determined by histological examination of liver biopsy (LAFSc)].
Measured: 7 Days
Secondary outcomes (2)
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.
Measured: 7 Days
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.
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Jul 2023 (estimated)
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FibrosisStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiang Xia, Prof. MD, Study chair, Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTUHao Feng, MD., Ph.D., Principal investigator, Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926778
- Sponsor's protocol ID
- Renji-LY2023-075-B
- Status last verified
- Jun 2023
- First submitted
- 6 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiomics Study of Fibrosis Factors After Liver Transplantation and Exploration of Fibrosis Methylation Biomarkers
- ClinicalTrials.gov ID
- NCT05926778
- Acronym / sponsor ID
- Renji-LY2023-075-B
- Conditions
- Liver Fibrosis
- Keywords
- Liver Fibrosis, Liver Transplantation, Biomarkers, DNA methylation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a retrospective study on 60 patients who had previously received liver transplantation in our hospital. The patients will be stratified according to age, including 20 children and 20 adults with allograft liver fibrosis after liver transplantation, while 10 children and 10 adults with fibrosis, respectively.
- The differential analysis of DNA-methylation will be performed between the allograft liver fibrosis cohort and the control cohort based on the GM-seq sequencing data. And the fibrosis-specific DNA-methylation CpG sites or regions in liver and peripheral blood will be explored in the liver transplantation recipients.
- The abundance and diversity of TCR between the allograft liver fibrosis cohort and the control cohort will be analyzed. And the fibrosis-specific TCR sequence of allograft liver fibrosis will be screened based on TCR-Seq sequencing and tNGS.
- The characteristics of DNA-methylation and TCR-Seq biomarkers in allograft liver fibrosis population will be defined. And the similarities and differences of the characteristics between children and adults will be explored.
- Based on the GM-seq and Tcr-Seq data, a novel diagnostic model including DNA-methylation and TCR-Seq biomarkers will be established.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibrosis Cohort | – | Other: Liver allograft fibrosisAdult(10 patients) and pediatric(10 patients) liver transplant recipients with fibrosis determined by histological examination of liver biopsy |
| Control Cohort | – | –Adult(20 patients) and pediatric(20 patients) liver transplant recipients without fibrosis determined by histological examination of liver biopsy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult or pediatric recipients who underwent liver transplantation
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver allograft fibrosisObservational studies without intervention | Other | Fibrosis Cohort |
Primary outcome
Sensivity
Time frame: 7 Days
Sensivity is the true positive rate of the novel diagnostic model [Liver fibrosis is determined by histological examination of liver biopsy (LAFSc)].
Specificity
Time frame: 7 Days
Specificity is the true negative rate of the novel diagnostic model [Liver fibrosis is determined by histological examination of liver biopsy (LAFSc)].
AUROC
Time frame: 7 Days
AUROC is the area under the receiver operating characteristic curve [Liver fibrosis is determined by histological examination of liver biopsy (LAFSc)].
2 secondary outcomes
Heterogeneity of the DNA-methylation biomarkers in allograft liver fibrosis cohort
Time frame: 7 Days
Heterogeneity of the TCR-Seq biomarkers in allograft liver fibrosis cohort
Time frame: 7 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qiang Xia, Prof. MD study chair
Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU
Hao Feng, MD., Ph.D. principal investigator
Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Fibrosis, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao Feng, MD., Ph.D. (008615000901110, surgeonfeng@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensivity (time frame: 7 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023; AzTrials last refreshed its copy on 8 Nov 2026.