Clinical trial NCT05600959: Sensitivity and Specificity of Cytokines in the Diagnosis of Lymphoma-associated HLH
Official title: The Role of Cytokines in Early Diagnosis, Assessment of Response and Prognosis of Patients With Lymphoma-associated Hemophagocytic Lymphohistiocytosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hemophagocytic Lymphohistiocytoses
Lymphoma
Keywords: Hemophagocytic Lymphohistiocytosis
Lymphoma
Cytokine
Diagnosis
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lymhoma and patients with lymphoma-associated HLH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The sensitivity and specificity of cytokines to predict lymphoma-associated HLH
timeFrame: 1 year
Secondary outcomes:
measure: Dynamic changes of cytokine levels during treatment
timeFrame: 1 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Zhao Wang
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Zhao Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: