Research on the Monitoring, Pathogen Screening, and Diagnostic System for Unexplained and Newly Emerging Acute Hepatitis

NCT06653140 | Not Yet Recruiting

• 1 other identifier: 2023YFC2306901
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis of Unknown Aetiology

Keywords

Unexplained hepatitis

Outcome Measures

Primary Outcomes (1)

• Forms of outcomes

  Validation of the Diagnostic Performance of the Monitoring Network and Early Warning System for Unexplained and Newly Emerging Acute Hepatitis

  three years

Other Outcomes (1)

• Forms of outcomes

  three years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Based on the suspected acute hepatitis case samples collected nationwide and the newly discovered suspected cases of unexplained and newly emerging acute hepatitis from the monitoring systems of the research centers participating in this study from 2024 to 2026.

You may qualify if:

• Exhibiting symptoms of acute hepatitis;
• Medical history, signs, and auxiliary examinations suggest hepatitis, but the cause is unknown or it is non-hepatotropic viral hepatitis;
• Newly discovered pathogen infection or hepatitis caused by factors other than currently known ones;
• The subject voluntarily participates in this study and signs the informed consent form.

You may not qualify if:

• Patients with a clear etiology and diagnosis of hepatitis;
• Patients who refuse to cooperate with sampling and sign the informed consent form;
• Those deemed unsuitable for participation in this study by the researchers.

Sponsors & Collaborators

• Minghui Li: lead

Study Sites (1)

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100015, China

Location

Related Publications (1)

• Sergi CM. Acute Hepatitis of Unknown Origin (AHUO)-The Puzzle Ahead. Diagnostics (Basel). 2022 May 12;12(5):1215. doi: 10.3390/diagnostics12051215.

  PMID: 35626370 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood, feces, liver tissue

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 22, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)