Application of Nanopore Adaptive Sequencing

NCT ID: NCT06542042

Last Updated: 2024-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-01

Study Completion Date

2026-10-30

Brief Summary

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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

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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

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Liver Transplant Infection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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NAS group

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

NAS, NGS and Laboratory tests

Intervention Type DIAGNOSTIC_TEST

Using three diffrent detection methods and comparing their efficiency

NGS group

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

NAS, NGS and Laboratory tests

Intervention Type DIAGNOSTIC_TEST

Using three diffrent detection methods and comparing their efficiency

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.

NAS, NGS and Laboratory tests

Intervention Type DIAGNOSTIC_TEST

Using three diffrent detection methods and comparing their efficiency

Interventions

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NAS, NGS and Laboratory tests

Using three diffrent detection methods and comparing their efficiency

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shenzhen Third People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lin Zhong, Dr

Role: PRINCIPAL_INVESTIGATOR

Shenzhen Third People's Hospital

Locations

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Shenzhen Third People's Hospital

Shenzhen, Guangdong, China

Site Status

Countries

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China

Central Contacts

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pusen Wang, Dr

Role: CONTACT

18621006138

Facility Contacts

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Lin Zhong, Dr

Role: primary

13917603139

References

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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.

Reference Type RESULT
PMID: 36259361 (View on PubMed)

Other Identifiers

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2022YFC2304700

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SZSY001

Identifier Type: -

Identifier Source: org_study_id

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