Application of Nanopore Adaptive Sequencing

Not yet recruiting

• Conditions: Liver Transplant Infection
• Interventions: Diagnostic Test: NAS, NGS and Laboratory tests

• Registration Number: NCT06542042
• Lead Sponsor: Shenzhen Third People's Hospital

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.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-27
• Study First Submitted QC: 2024-08-06
• Last Update Submitted: 2024-08-06
• Study First Posted: 2024-08-07
• Last Update Posted: 2024-08-07
• Study Start: 2024-10-01
• Primary Completion: 2026-08-01
• Study Completion: 2026-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NGS group	NAS, NGS and Laboratory tests	In this group, the investigators will detect the number of pathogen in alveolar lavage fluid, blood and peritoneal drainage by using NGS.
NAS group	NAS, NGS and Laboratory tests	In this group, the investigators will detect the number of pathogen in alveolar lavage fluid, blood and peritoneal drainage by using NAS.
Lab Tests group	NAS, NGS and Laboratory tests	In this group, the investigators will detect the number of pathogen in alveolar lavage fluid, blood and peritoneal drainage by using laboratory tests.

Primary Outcome Measures

Name	Time	Method
Diagnosed infection post liver transplantation	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

Trial Locations

Locations (1)

Shenzhen Third People's Hospital; 🇨🇳 Shenzhen, Guangdong, China