Application of Nanopore Adaptive Sequencing

NCT06542042 | Not Yet Recruiting

• 2 other identifiers: SZSY0012022YFC2304700
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplant Infection

Keywords

Oxford nanopore adaptive sequencing method

Outcome Measures

Primary Outcomes (1)

• 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

  Post liver transplantation before patients discharge from hospital, an average of 1 months.

Study Arms (3)

NAS group

In this group, the investigators will detect the number of pathogen in alveolar lavage fluid, blood and peritoneal drainage by using NAS.

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.

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.

Diagnostic Test: NAS, NGS and Laboratory tests

Interventions

NAS, NGS and Laboratory tests DIAGNOSTIC_TEST

Using three diffrent detection methods and comparing their efficiency

Lab Tests group; NAS group; NGS group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shenzhen Third People's Hospital: lead

Study Sites (1)

Shenzhen Third People's Hospital

Shenzhen, Guangdong, China

Location

Related Publications (1)

• 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.

  PMID: 36259361 RESULT

Study Officials

• Lin Zhong, Dr

  Shenzhen Third People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

pusen Wang, Dr

CONTACT

18621006138; pusenwang@sjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: August 7, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: August 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)