Sensitivity and Specificity of Cytokines in the Diagnosis of Lymphoma-associated HLH

Not yet recruiting

• Conditions: Lymphoma; Hemophagocytic Lymphohistiocytoses
• Interventions: Diagnostic Test: cytokine

• Registration Number: NCT05600959
• Lead Sponsor: Beijing Friendship Hospital

Brief Summary

Lymphoma-associated hemophagocytic lympohistiocytosis is a refractory immune disorder with high mortality. Early identification and diagnosis of lymphoma-associated HLH has become the key to improve the prognosis of lymphoma-associated HLH. Therefore, we conduct a multicenter, prospective, observational clinical study to explore the sensitivity and specificity of cytokines for the early diagnosis of lymphoma-associated HLH.

Detailed Description

Lymphoma-associated hemophagocytic lympohistiocytosis is a refractory immune disorder with high mortality. Without early intervention, the median survival time is less than 2 months. Early identification and diagnosis of lymphoma-associated HLH has become the key to improve the prognosis of lymphoma-associated HLH. Therefore, it is urgent to find a method for the early diagnosis of lymphoma-associated HLH. We conduct a multicenter, prospective, observational clinical study to explore the sensitivity and specificity of cytokines for the early diagnosis of lymphoma-associated HLH, and its correlation with disease severity, treatment response, and prognosis.

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-27
• Study First Submitted QC: 2022-10-27
• Last Update Submitted: 2022-10-27
• Study Start: 2022-11-01
• Study First Posted: 2022-11-01
• Last Update Posted: 2022-11-01
• Primary Completion: 2025-11-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age 40-75, gender is not limited.
• Patients with histopathologically confirmed lymphoma who meet HLH-04 diagnostic criteria, and did not receive systemic chemotherapy before enrollment.
• Patients with histopathologically confirmed lymphoma who did not receive systemic chemotherapy before enrollment.
• Informed consent obtained.

Exclusion Criteria

• Patients with severe active infections (viral, bacterial, fungal, or parasitic).
• Patients with active autoimmune disease or a history of organ transplantation who are receiving immunosuppressive therapy.
• Patients with other type of malignant tumors within 5 years, except for cured solid tumors.
• Patients planned to receive immunotherapy.
• Pregnant and breastfeeding females.
• History of human immunodeficiency virus (HIV) infection.
• Acute or chronic active hepatitis B or hepatitis C.
• Patients assessed as ineligible for the study by the investigator.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lymphoma-associated HLH group	cytokine	Patients with histopathologically confirmed lymphoma who meet HLH-04 diagnostic criteria, and did not receive systemic chemotherapy before enrollment.
Lymphoma group	cytokine	Patients with histopathologically confirmed lymphoma who did not receive systemic chemotherapy before enrollment.

Primary Outcome Measures

Name	Time	Method
The sensitivity and specificity of cytokines to predict lymphoma-associated HLH	1 year	The sensitivity and specificity of cytokines as a means of early diagnosis of lymphoma-associated hemophagocytic lymphohistiocytosis

Secondary Outcome Measures

Name	Time	Method
Dynamic changes of cytokine levels during treatment	1 years	To monitor the correlation between cytokine levels and disease severity, treatment response and prognosis of lymphoma-associated hemophagocytic lymphohistiocytosis

Trial Locations

Locations (1)

Zhao Wang; 🇨🇳 Beijing, Beijing, China