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

NCT ID: NCT06614998

Last Updated: 2024-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2026-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hemophagocytic Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

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

Intervention Type 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

Interventions

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

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Subjects must meet all of the following criteria:

1. Patients who meet the first step screening + have ≥ 3 abnormal screening indicators in the second step
2. 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Hospital of Xuzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Affilitated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei Sang, Doctor

Role: CONTACT

13645207648

Facility Contacts

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Wei Sang, Docter

Role: primary

13645207648

Other Identifiers

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XYFY2024-KL100-01

Identifier Type: -

Identifier Source: org_study_id

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