Liver Transplant InfectionNCT06542042
Application of Nanopore Adaptive Sequencing
An observational study of Liver Transplant Infection, run by Shenzhen Third People's Hospital at 1 site in China.
Trial summary
Infection post liver transplantation is an important factor in the death in patients. The traditional method of diagnosing infection post liver transplantation is laboratory tests. But the sensitivity and specificity of blood tests is poor. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Transplant Infection
- What is being tested?
- NAS, NGS and Laboratory tests
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 30 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Participants will be recruited randomly and if they violate the protocol or occur clinical adverse events, the investigators will ask them to withdraw from this study.
Who may be able to join
- Accept liver transplantation
- Signing informed consent voluntarily
- Possessing ability to comprehend material information
- Participating this study voluntarily
Who cannot join
- Participated another study
- Graft loss
- Have undergone a multi-organ transplantion or have had a previous organ transplantation
- Patient died
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shenzhen Third People's Hospital
Shenzhen, Guangdong
Lin Zhong, Dr, 13917603139, zhonglin1@medmail.com.cn
About this study
Official title: Application of Oxford Nanopore Adaptive Sequencing Method in Infection Post Liver Transplantation
Infection post liver transplantation is an important factor in the death in patients. The traditional method of diagnosing infection post liver transplantation is laboratory tests. But the sensitivity and specificity of blood tests is poor. Next-generation sequencing (NGS) has greater detection rate for mycobacterium tuberculosis, anaerobes and fungi and greater sensitivity compare with blood tests. However use of NGS is limited because of the short read-length. Oxford nanopore adaptive sequencing (NAS) method is the Third Revolution in Sequencing Technology. For each 1 Gbp of data, NAS sequencing detected 45 times more microbiome sequences than Nanopore standard sequencing and 2.5 times more than Illumina sequencing. The purpose of this study is to compare NAS with NGS and laboratory tests for the diagnostic rate of infection post liver transplantation.
Read the detailed description
Based on the previous work, the investigators found that: 1. NAS has a higher microbial enrichment efficiency and can detect pathogenic information more quickly compared with nanopores normal sequencing (NNS); 2. NAS can detect more specific pathogen fragments with short-time sequencing; 3. NAS can cover more pathogenic genomes than NNS in a short-time; 4. NAS can detect antibiotic resistance information of pathogenic bacteria in clinical samples.
- Conditions
- Liver Transplant Infection
- Being tested
- NAS, NGS and Laboratory tests
- Keywords
- Oxford nanopore adaptive sequencing method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAS, NGS and Laboratory testsDiagnostic test
Using three diffrent detection methods and comparing their efficiency
| Study group | Role | What they receive |
|---|---|---|
| NAS group | In this group, the investigators will detect the number of pathogen in alveolar lavage fluid, blood and peritoneal drainage by using NAS. Receives: Diagnostic Test: NAS, NGS and Laboratory tests | |
| NGS group | In this group, the investigators will detect the number of pathogen in alveolar lavage fluid, blood and peritoneal drainage by using NGS. Receives: Diagnostic Test: NAS, NGS and Laboratory tests | |
| Lab Tests group | In this group, the investigators will detect the number of pathogen in alveolar lavage fluid, blood and peritoneal drainage by using laboratory tests. Receives: Diagnostic Test: NAS, NGS and Laboratory tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosed infection post liver transplantation
Any pathogens are detected in alveolar lavage fluid, peritoneal drainage or blood before patients discharge from hospital, an average of 1 months
Measured: Post liver transplantation before patients discharge from hospital, an average of 1 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver Transplant InfectionStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Third People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lin Zhong, Dr, Principal investigator, Shenzhen Third People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542042
- Sponsor's protocol ID
- SZSY001
- Other IDs
- 2022YFC2304700
- Status last verified
- Jun 2024
- First submitted
- 27 Jun 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheng H, Sun Y, Yang Q, Deng M, Yu Z, Zhu G, Qu J, Liu L, Yang L, Xia Y. A rapid bacterial pathogen and antimicrobial resistance diagnosis workflow using Oxford nanopore adaptive sequencing method. Brief Bioinform. 2022 Nov 19;23(6):bbac453. doi: 10.1093/bib/bbac453.
PubMed 36259361
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Oxford Nanopore Adaptive Sequencing Method in Infection Post Liver Transplantation
- ClinicalTrials.gov ID
- NCT06542042
- Acronym / sponsor ID
- SZSY001
- Conditions
- Liver Transplant Infection
- Keywords
- Oxford nanopore adaptive sequencing method
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shenzhen Third People's HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 7 Aug 2024 (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.
Infection post liver transplantation is an important factor in the death in patients. The traditional method of diagnosing infection post liver transplantation is laboratory tests. But the sensitivity and specificity of blood tests is poor. Next-generation sequencing (NGS) has greater detection rate for mycobacterium tuberculosis, anaerobes and fungi and greater sensitivity compare with blood tests. However use of NGS is limited because of the short read-length. Oxford nanopore adaptive sequencing (NAS) method is the Third Revolution in Sequencing Technology. For each 1 Gbp of data, NAS sequencing detected 45 times more microbiome sequences than Nanopore standard sequencing and 2.5 times more than Illumina sequencing. The purpose of this study is to compare NAS with NGS and laboratory tests for the diagnostic rate of infection post liver transplantation.
Detailed description
Based on the previous work, the investigators found that: 1. NAS has a higher microbial enrichment efficiency and can detect pathogenic information more quickly compared with nanopores normal sequencing (NNS); 2. NAS can detect more specific pathogen fragments with short-time sequencing; 3. NAS can cover more pathogenic genomes than NNS in a short-time; 4. NAS can detect antibiotic resistance information of pathogenic bacteria in clinical samples.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NAS group | – | Diagnostic Test: NAS, NGS and Laboratory testsIn this group, the investigators will detect the number of pathogen in alveolar lavage fluid, blood and peritoneal drainage by using NAS. |
| NGS group | – | Diagnostic Test: NAS, NGS and Laboratory testsIn this group, the investigators will detect the number of pathogen in alveolar lavage fluid, blood and peritoneal drainage by using NGS. |
| Lab Tests group | – | Diagnostic Test: NAS, NGS and Laboratory testsIn this group, the investigators will detect the number of pathogen in alveolar lavage fluid, blood and peritoneal drainage by using laboratory tests. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will be recruited randomly and if they violate the protocol or occur clinical adverse events, the investigators will ask them to withdraw from this study.
Key inclusion criteria (4 listed)
- Accept liver transplantation
- Signing informed consent voluntarily
- Possessing ability to comprehend material information
- Participating this study voluntarily
Key exclusion criteria (4 listed)
- Participated another study
- Graft loss
- Have undergone a multi-organ transplantion or have had a previous organ transplantation
- Patient died
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 |
|---|---|---|
| NAS, NGS and Laboratory testsUsing three diffrent detection methods and comparing their efficiency | Diagnostic test | Lab Tests group, NAS group, NGS group |
Primary outcome
Diagnosed infection post liver transplantation
Time frame: Post liver transplantation before patients discharge from hospital, an average of 1 months.
Any pathogens are detected in alveolar lavage fluid, peritoneal drainage or blood before patients discharge from hospital, an average of 1 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Results publication: PubMed 36259361Cheng H, Sun Y, Yang Q, Deng M, Yu Z, Zhu G, Qu J, Liu L, Yang L, Xia Y. A rapid bacterial pathogen and antimicrobial resistance diagnosis workflow using Oxford nanopore adaptive sequencing method. Brief Bioinform. 2022 Nov 19;23(6):bbac453. doi: 10.1093/bib/bbac453.
- 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.
Lin Zhong, Dr principal investigator
Shenzhen Third People's Hospital
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 Transplant Infection, run by Shenzhen Third People's 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 7 Aug 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact pusen Wang, Dr (18621006138, pusenwang@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosed infection post liver transplantation (time frame: Post liver transplantation before patients discharge from hospital, an average of 1 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06542042, which also lists 1 linked publication.
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 7 Aug 2024.