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

Sponsor

Beijing Friendship Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05600959

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemophagocytic Lymphohistiocytoses Lymphoma	Diagnostic Test: cytokine

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

60 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Lymphoma group Patients with histopathologically confirmed lymphoma who did not receive systemic chemotherapy before enrollment.	Diagnostic Test: cytokine 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.
Lymphoma-associated HLH group Patients with histopathologically confirmed lymphoma who meet HLH-04 diagnostic criteria, and did not receive systemic chemotherapy before enrollment.	Diagnostic Test: cytokine 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.

Arm

Intervention/Treatment

Lymphoma group

Patients with histopathologically confirmed lymphoma who did not receive systemic chemotherapy before enrollment.

Diagnostic Test: cytokine

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.

Lymphoma-associated HLH group

Patients with histopathologically confirmed lymphoma who meet HLH-04 diagnostic criteria, and did not receive systemic chemotherapy before enrollment.

Diagnostic Test: cytokine

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.