Response Prediction in EBV-HLH Using Metabonomics Analysis

Not yet recruiting

• Conditions: Hemophagocytic Lymphohistiocytoses; EBV; Metabonomics
• Interventions: Other: observational

• Registration Number: NCT05677178
• Lead Sponsor: Beijing Friendship Hospital

Brief Summary

Hemophagocytic lymphohistiocytosis (HLH) is a rare, poorly recognized and underdiagnosed syndrome of excessive immune activation, which is rapidly fatal. Epstein-Barr virus (EBV) is a common trigger of HLH, particularly in Asian individuals. We aim to analyze metabolomics and cytokine profiles of patients before and after treatment to explore the metabolomic characteristics of EBV-HLH, and search for pathogenic mechanisms and therapeutic targets.

Detailed Description

Hemophagocytic lymphohistiocytosis (HLH) is a rare, poorly recognized and underdiagnosed syndrome of excessive immune activation, which is rapidly fatal. Without early intervention, the median survival time is less than 2 months.Epstein-Barr virus (EBV) is a common trigger of HLH, particularly in Asian individuals. We aim to analyze metabolomics and cytokine profiles of patients before and after treatment to explore the metabolomic characteristics of EBV-HLH, and search for pathogenic mechanisms and therapeutic targets.

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-10
• Study First Submitted QC: 2022-12-22
• Last Update Submitted: 2022-12-22
• Study Start: 2023-01-01
• Study First Posted: 2023-01-10
• Last Update Posted: 2023-01-10
• Primary Completion: 2024-12-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients who meet HLH-04 diagnostic criteria
• EBV-DNA viral load in the peripheral blood > 500 copies/mL
• Informed consent obtained.

Exclusion Criteria

• refuse to participate.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
survival group	observational	Patients who survived 2 months after treatment.
death group	observational	Patients who died 2 months after treatment.

Primary Outcome Measures

Name	Time	Method
Difference in metabonomics pattern between subgroups	2 months	Compare metabonomics pattern of the survival group with that of the death group, identify potential predictors of outcomes, and establish a survival prediction model in patients with EBV-HLH. Measure metabolite levels.
Difference in cytokine pattern between subgroups	2 months	Compare metabonomics and cytokine pattern of the survival group with that of the death group, identify potential predictors of outcomes, and establish a survival prediction model in patients with EBV-HLH. Measure cytokine levels.

Trial Locations

Locations (1)

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China