Response Prediction in EBV-HLH Using Metabonomics Analysis

Hemophagocytic Lymphohistiocytoses Clinical Trial

Official title:

Response Prediction in EBV-HLH Using Metabonomics Analysis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05677178
• Other study ID #: 2022-P2-092-01
• Status: Not yet recruiting
• Start date: January 1, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: November 2022
• Source: Beijing Friendship Hospital
• Contact: Zhao Wang, MD
• Phone: +861083138303
• Email: wangzhao[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• EBV
• Hemophagocytic Lymphohistiocytoses
• Lymphohistiocytosis, Hemophagocytic

Intervention

Other:
• observational
This study is an observational study without any intervention.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in metabonomics pattern between subgroups	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.	2 months
Primary	Difference in cytokine pattern between subgroups	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.	2 months