Establishment of an Early Warning Screening System for Hemophagocytic Lymphohistiocytosis a Multi-center, Prospective Study

NCT06614998 | Recruiting

• 1 other identifier: XYFY2024-KL100-01
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Our three-step screening system uses commonly used clinical and laboratory parameters to effectively identify patients who may be at high risk of HLH, conduct etiology screening early for patients who meet the diagnostic criteria for HLH, and guide standardized treatment. Therefore, this study proposes to establish a highly accurate and convenient hemophagocytic early warning system to improve the early diagnosis of patients with hemophagocytic syndrome and identify suspected HLH patients early. Etiology screening is performed on patients who meet the diagnostic criteria for HLH, high-risk predisposing factors are identified, and precise treatment is guided, thereby improving the success rate of patient treatment and improving the quality of life.

Conditions

Hemophagocytic Syndrome

Keywords

hemophagocytic syndrome screening system

Outcome Measures

Primary Outcomes (1)

• The suspected patient was diagnosed with hemophagocytic syndrome after complete NK cell activity, triglyceride tests, etc.

  Time forecasting:2 years

Study Arms (1)

Screening patients with suspected hemophagocytic syndrome

Preliminary screening of patients with elevated ferritin and low fibrinogen, and then continue to improve triglycerides, abdominal color ultrasound and other examinations to further clarify, for some very suspicious patients, timely improve genes, NK cell activity and other tests, as soon as possible to determine whether they are patients with hemophagocytic syndrome

Drug: Patients diagnosed with HLH-94 should be treated as soon as possible

Interventions

Patients diagnosed with HLH-94 should be treated as soon as possible DRUG

For some highly suspicious patients, after diagnosis, according to the patient's etiology, the treatment plan should be determined as soon as possible, such as lymphoma-related patients treated with hormones combined with etoposide, which can greatly improve the prognosis of patients

Screening patients with suspected hemophagocytic syndrome

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A three-step screening process identified 80 people with suspected hemophagocytic syndrome

You may qualify if:

• Subjects must meet all of the following criteria:
• Patients who meet the first step screening + have ≥ 3 abnormal screening indicators in the second step
• Patients who meet the first step screening + have 2 abnormal screening indicators in the second step + patients with high-risk factors for HLH, such as history of lymphoma, EBV infection, autoimmune diseases, etc

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University: lead

Study Sites (1)

Affilitated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221006, China

RECRUITING

MeSH Terms

Conditions

Lymphohistiocytosis, Hemophagocytic

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Wei Sang, Doctor

CONTACT

13645207648; sw1981726@126.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: September 26, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)