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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Role of Cytokines in Early Diagnosis, Assessment of Response and Prognosis of Patients With Lymphoma-associated Hemophagocytic Lymphohistiocytosis

Conditions
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Hemophagocytic Lymphohistiocytoses, Lymphoma

Intervention / Treatment
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* Diagnostic Test: cytokine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lymphoma group<br>Patients with histopathologically confirmed lymphoma who did not receive systemic chemotherapy before enrollment. | Diagnostic Test: cytokine<br>* Peripheral blood samples were collected at diagnosis, 2 weeks after the first cycle of chemotherapy and 2 weeks after the second cycle of chemotherapy to monitor cytokine level changes.<br>|
| Lymphoma-associated HLH group<br>Patients with histopathologically confirmed lymphoma who meet HLH-04 diagnostic criteria, and did not receive systemic chemotherapy before enrollment. | Diagnostic Test: cytokine<br>* Peripheral blood samples were collected at diagnosis, 2 weeks after the first cycle of chemotherapy and 2 weeks after the second cycle of chemotherapy to monitor cytokine level changes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sensitivity and specificity of cytokines to predict lymphoma-associated HLH | The sensitivity and specificity of cytokines as a means of early diagnosis of lymphoma-associated hemophagocytic lymphohistiocytosis | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic changes of cytokine levels during treatment | To monitor the correlation between cytokine levels and disease severity, treatment response and prognosis of lymphoma-associated hemophagocytic lymphohistiocytosis | 1 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemophagocytic Lymphohistiocytosis, Lymphoma, Cytokine, Diagnosis