Clinical trial NCT06542042: Application of Nanopore Adaptive Sequencing
Official title: Application of Oxford Nanopore Adaptive Sequencing Method in Infection Post Liver Transplantation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Liver Transplant Infection
Keywords: Oxford nanopore adaptive sequencing method
Lead sponsor: Shenzhen Third People's Hospital
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Accept liver transplantation
* Signing informed consent voluntarily
* Possessing ability to comprehend material information
* Participating this study voluntarily

Exclusion Criteria:

* Participated another study
* Graft loss
* Have undergone a multi-organ transplantion or have had a previous organ transplantation
* Patient died

Primary outcomes:
measure: Diagnosed infection post liver transplantation
timeFrame: Post liver transplantation before patients discharge from hospital, an average of 1 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Third People's Hospital
state: Guangdong
Study officials:
affiliation: Shenzhen Third People's Hospital
name: Lin Zhong, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.