CClinicalTrials.gg
Not yet recruitingNCT05600959Updated Nov 1, 2022

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

An observational study in Hemophagocytic Lymphohistiocytoses and Lymphoma, sponsored by Beijing Friendship Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-11-01.

Sponsored by Beijing Friendship Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2025, 11 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hemophagocytic Lymphohistiocytoses
  • Lymphoma

Keywords

  • Hemophagocytic Lymphohistiocytosis
  • Lymphoma
  • Cytokine
  • Diagnosis
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 60 is below the median of 136 across 625 observational studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Beijing Friendship Hospital is the lead sponsor of 216 studies on the registry; 95 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with lymhoma and patients with lymphoma-associated HLH

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

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.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
60 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • 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

  • Diagnostic testcytokine

    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.

06

What researchers measure

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

    Time frame: 1 year

Secondary outcomes

  1. 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

    Time frame: 1 years

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05600959
Lead sponsor
Beijing Friendship Hospital
Responsible party
Zhao Wang (Professor and Head of hematology, Beijing Friendship Hospital) — Principal investigator
First posted
Nov 1, 2022
Start date
Nov 1, 2022 (estimated)
Primary completion
Nov 1, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Nov 1, 2022

Study contacts

Zhao Wang
Contact
wangzhao@ccmu.edu.cn
63138303
Zhao Wang, MD
principal investigator · Beijing Friendship Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion