Response Prediction in EBV-HLH Using Metabonomics Analysis

NCT05677178 | Unknown

• 1 other identifier: 2022-P2-092-01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemophagocytic Lymphohistiocytoses; EBV; Metabonomics

Keywords

Hemophagocytic Lymphohistiocytoses; EBV; matabonomics

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

survival group

Patients who survived 2 months after treatment.

Other: observational

death group

Patients who died 2 months after treatment.

Other: observational

Interventions

observational OTHER

This study is an observational study without any intervention.

death group; survival group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients who were diagnosed with EBV-HLH in China.

You may qualify if:

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

You may not qualify if:

• refuse to participate.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

MeSH Terms

Conditions

Lymphohistiocytosis, Hemophagocytic

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Zhao Wang, MD

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhao Wang, MD

CONTACT

+861083138303; wangzhao@ccmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the hematology department

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: January 10, 2023
• Study Start: January 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: January 10, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)