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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05600959
Enrollment
60
Registered
2022-11-01
Start date
2022-11-01
Completion date
2025-12-31
Last updated
2022-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophagocytic Lymphohistiocytoses, Lymphoma

Keywords

Hemophagocytic Lymphohistiocytosis, Lymphoma, Cytokine, Diagnosis

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.

Interventions

DIAGNOSTIC_TESTcytokine

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.

Sponsors

Beijing Friendship Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The sensitivity and specificity of cytokines to predict lymphoma-associated HLH1 yearThe sensitivity and specificity of cytokines as a means of early diagnosis of lymphoma-associated hemophagocytic lymphohistiocytosis

Secondary

MeasureTime frameDescription
Dynamic changes of cytokine levels during treatment1 yearsTo monitor the correlation between cytokine levels and disease severity, treatment response and prognosis of lymphoma-associated hemophagocytic lymphohistiocytosis

Countries

China

Contacts

Primary ContactZhao Wang
wangzhao@ccmu.edu.cn63138303

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026