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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lymphoma; Hemophagocytic Lymphohistiocytoses
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Zhao Wang; Phone Number: 63138303; Email: wangzhao@ccmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Zhao Wang
      • Contact: Zhao Wang, MD; Phone Number: 63138303; Email: wangzhao@ccmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with lymhoma and patients with lymphoma-associated HLH

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Investigators: Principal Investigator: Zhao Wang, MD, Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): November 1, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): November 1, 2022

Study Record Updates

• Last Update Posted (Actual): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 27, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Lymphoma; Diagnosis; Cytokine; Hemophagocytic Lymphohistiocytosis
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Lymphoma; Lymphohistiocytosis, Hemophagocytic
• Other Study ID Numbers: BFH20221009001/BFHHZML20220006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No