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

NCT05600959 | Unknown

• 1 other identifier: BFH20221009001/BFHHZML20220006
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemophagocytic Lymphohistiocytoses; Lymphoma

Keywords

Hemophagocytic Lymphohistiocytosis; Lymphoma; Cytokine; Diagnosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Dynamic changes of cytokine levels during treatment

  1 years

Study Arms (2)

Lymphoma group

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

Diagnostic Test: cytokine

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

Interventions

cytokine DIAGNOSTIC_TEST

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 group; Lymphoma-associated HLH group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with lymhoma and patients with lymphoma-associated HLH

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Zhao Wang

Beijing, Beijing Municipality, 100050, China

Location

MeSH Terms

Conditions

Lymphohistiocytosis, Hemophagocytic; Lymphoma; Disease

Interventions

Th1-Th2 Balance

Condition Hierarchy (Ancestors)

Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immune System Phenomena

Study Officials

• Zhao Wang, MD

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhao Wang

CONTACT

63138303; wangzhao@ccmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head of hematology

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 1, 2022
• Study Start: November 1, 2022
• Primary Completion: November 1, 2025
• Study Completion: December 31, 2025
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)