Nationwide survey on hemophagocytic syndrome as an immune-related adverse event in the treatment of malignant thoracic tumors

Nationwide survey on hemophagocytic syndrome as an immune-related adverse event in the treatment of malignant thoracic tumors - Nationwide survey on hemophagocytic syndrome as an immune-related adverse event in the treatment of malignant thoracic tumors

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000061557

Enrollment

Registered

2026-05-13

Start date

2025-03-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant thoracic tumor

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Cases using immune checkpoint inhibitors in the treatment of malignant thoracic tumors. 2)Cases in which hemophagocytic syndrome (HPS) developed as an immune-related adverse event,HPS was clinically diagnosed based on the HLH-2004 criteria. 1. The patient is currently undergoing or has completed treatment with an immune checkpoint inhibitor 2. At least 5 of the following 8 items are satisfied: 1 Fever 2 Splenomegaly 3 Cytopenia of 2 or more cell lines in peripheral blood (Hemoglobin < 9.0 g/dL, Platelets < 100,000/uL, Neutrophils < 1,000/uL) 4 Fasting triglycerides >= 265 mg/dL or Fibrinogen <= 1.5 g/L 5 Hemophagocytosis observed in bone marrow / spleen / lymph nodes / liver 6 Low or absent NK cell activity (per institutional criteria) 7 Ferritin >= 500 ng/mL 8 Soluble IL-2 receptor >= 2,400 U/mL 3)Other causes of hemophagocytic syndrome have been excluded.

Exclusion criteria

Exclusion criteria: 1)Cases in which the subject is found not to meet the eligibility criteria after enrollment in this study 2)Individuals who have submitted a request to withdraw from participation in this study

Design outcomes

Primary

Measure	Time frame
Frequency of hemophagocytic syndrome as an immune-related adverse event in malignant thoracic tumors.	—

Secondary

Measure	Time frame
Clinical characteristics, treatment course, prognosis, and therapeutic efficacy of immune checkpoint inhibitors in patients who developed hemophagocytic syndrome.	—

Countries

Japan

Contacts

Public ContactYuko Iida

Nihon University School of Medicine Division of Respiratory Medicine, Department of Internal Medicine

iida.yuko@nihon-u.ac.jp03-3972-8111

Outcome results