Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06653140
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
Research on the Monitoring Pathogen Screening and Diagnostic System for Unexplained and Newly Emerging Acute Hepatitis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Research on the Monitoring Pathogen Screening and Diagnostic System for Unexplained and Newly Emerging Acute Hepatitis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This project will collect blood and liver tissue samples of unexplained and newly emerging acute hepatitis through a monitoring system After excluding infections of hepatitis A-E viruses using enzyme immunoassay chemical and photometric methods to detect infection markers multiplex PCR technology will be employed to screen for related pathogens The goal is to establish a sensitive rapid and accurate diagnostic system
Detailed Description:
Unexplained hepatitis refers to cases where patients exhibit acute hepatitis symptoms that are not caused by hepatitis A B C D or E viruses also known as non-hepatotropic viral hepatitis On March 31 2022 the UK first reported five cases of severe acute hepatitis of unknown origin in children Subsequently suspected cases were reported in multiple countries worldwide As of November 2022 1010 cases have been reported in 35 countries primarily affecting children under five years old with approximately 5 of cases requiring liver transplantation indicating a high severity rate Possible causes of unexplained hepatitis include infections by viruses other than hepatitis viruses and autoimmune reactions Newly emerging acute hepatitis refers to outbreaks of hepatitis caused by newly discovered pathogens or other factors Research has indicated that the etiology and pathogenesis of unexplained hepatitis in children are related to infections by human adenovirus adeno-associated virus 2 AAV2 and cytomegalovirus European countries conducted adenovirus testing on 457 children with a positivity rate of 516 236 cases Two studies in the UK found high levels of AAV2 in the blood and liver samples of some children through metagenomic sequencing and PCR testing although the specific pathogenesis remains unclear Unexplained hepatitis and newly emerging acute hepatitis can cause a significant disease burden Reports and discoveries in China are relatively rare To accurately understand the incidence and pathogenic mechanisms of unexplained and newly emerging acute hepatitis in China it is crucial to conduct monitoring pathogen screening and diagnostic system research This project aims to collect blood and liver tissue samples of unexplained and newly emerging acute hepatitis through a monitoring system After excluding infections of hepatitis A-E viruses using enzyme immunoassay chemical and photometric methods to detect infection markers multiplex PCR technology and other methods will be employed to establish a pathogen detection platform for unexplained hepatitis This will involve nucleic acid testing for common non-hepatotropic viruses that cause liver damage and constructing a stable multiplex PCR reaction system to achieve rapid screening and diagnosis of clinical samples Understanding the incidence and dynamic trends of unexplained and newly emerging acute hepatitis and studying their etiology and influencing factors through pathogen screening and diagnostic research will provide technical support for the prevention and control of these conditions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None