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Trial Title:
Sensitivity and Specificity of Cytokines in the Diagnosis of Lymphoma-associated HLH
NCT ID:
NCT05600959
Condition:
Hemophagocytic Lymphohistiocytoses
Lymphoma
Conditions: Official terms:
Lymphoma
Lymphohistiocytosis, Hemophagocytic
Conditions: Keywords:
Hemophagocytic Lymphohistiocytosis
Lymphoma
Cytokine
Diagnosis
Study type:
Observational [Patient Registry]
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
cytokine
Description:
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.
Arm group label:
Lymphoma group
Arm group label:
Lymphoma-associated HLH group
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.
Criteria for eligibility:
Study pop:
Patients with lymhoma and patients with lymphoma-associated HLH
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhao Wang
Address:
City:
Beijing
Zip:
100050
Country:
China
Contact:
Last name:
Zhao Wang, MD
Phone:
63138303
Email:
wangzhao@ccmu.edu.cn
Start date:
November 1, 2022
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Beijing Friendship Hospital
Agency class:
Other
Source:
Beijing Friendship Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05600959
