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

NCT ID: NCT05600959

Last Updated: 2022-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Hemophagocytic Lymphohistiocytoses Lymphoma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Lymphoma group

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

cytokine

Intervention Type 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-associated HLH group

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

cytokine

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhao Wang

Professor and Head of hematology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhao Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital

Locations

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Zhao Wang

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Zhao Wang

Role: CONTACT

Facility Contacts

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Zhao Wang, MD

Role: primary

Other Identifiers

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BFH20221009001/BFHHZML20220006

Identifier Type: -

Identifier Source: org_study_id

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