- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05677178
Response Prediction in EBV-HLH Using Metabonomics Analysis
December 22, 2022 updated by: Zhao Wang, Beijing Friendship Hospital
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhao Wang, MD
- Phone Number: +861083138303
- Email: wangzhao@ccmu.edu.cn
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100050
- Beijing Friendship Hospital, Capital Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who were diagnosed with EBV-HLH in China.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
survival group
Patients who survived 2 months after treatment.
|
This study is an observational study without any intervention.
|
death group
Patients who died 2 months after treatment.
|
This study is an observational study without any intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in metabonomics pattern between subgroups
Time Frame: 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.
|
2 months
|
Difference in cytokine pattern between subgroups
Time Frame: 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.
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zhao Wang, MD, Beijing Friendship Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2023
Primary Completion (Anticipated)
December 1, 2024
Study Completion (Anticipated)
March 1, 2025
Study Registration Dates
First Submitted
November 10, 2022
First Submitted That Met QC Criteria
December 22, 2022
First Posted (Estimate)
January 10, 2023
Study Record Updates
Last Update Posted (Estimate)
January 10, 2023
Last Update Submitted That Met QC Criteria
December 22, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-P2-092-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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