Response Prediction in EBV-HLH Using Metabonomics Analysis

Sponsor

Beijing Friendship Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05677178

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemophagocytic Lymphohistiocytoses EBV Metabonomics	Other: observational

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

30 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Response Prediction in EBV-HLH Using Metabonomics Analysis

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
survival group Patients who survived 2 months after treatment.	Other: observational This study is an observational study without any intervention.
death group Patients who died 2 months after treatment.	Other: observational This study is an observational study without any intervention.

Arm

Intervention/Treatment

survival group

Patients who survived 2 months after treatment.

Other: observational

This study is an observational study without any intervention.

death group

Patients who died 2 months after treatment.

Other: observational

This study is an observational study without any intervention.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing	China	100050

Sponsors and Collaborators

Beijing Friendship Hospital

Investigators

Principal Investigator: Zhao Wang, MD, Beijing Friendship Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zhao Wang, Head of the hematology department, Beijing Friendship Hospital

ClinicalTrials.gov Identifier:

NCT05677178

Other Study ID Numbers:

2022-P2-092-01

First Posted:

Jan 10, 2023

Last Update Posted:

Jan 10, 2023

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Zhao Wang, Head of the hematology department, Beijing Friendship Hospital

Hemophagocytic Lymphohistiocytoses

EBV

matabonomics

Additional relevant MeSH terms:

Lymphohistiocytosis, Hemophagocytic

Study Results

No Results Posted as of Jan 10, 2023