UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061557 |
|---|---|
| Receipt number | R000070423 |
| Scientific Title | Nationwide survey on hemophagocytic syndrome as an immune-related adverse event in the treatment of malignant thoracic tumors |
| Date of disclosure of the study information | 2026/05/13 |
| Last modified on | 2026/05/13 17:37:03 |
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Basic information
Public title
Nationwide survey on hemophagocytic syndrome as an immune-related adverse event in the treatment of malignant thoracic tumors
Acronym
Nationwide survey on hemophagocytic syndrome as an immune-related adverse event in the treatment of malignant thoracic tumors
Scientific Title
Nationwide survey on hemophagocytic syndrome as an immune-related adverse event in the treatment of malignant thoracic tumors
Scientific Title:Acronym
Nationwide survey on hemophagocytic syndrome as an immune-related adverse event in the treatment of malignant thoracic tumors
Region
| Japan |
Condition
Condition
Malignant thoracic tumor
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the clinical characteristics of cases of hemophagocytic syndrome caused by immune checkpoint inhibitors in patients with malignant thoracic tumors.
Basic objectives2
Others
Basic objectives -Others
Clinical characteristics of hemophagocytic syndrome as an immune-related adverse event in malignant thoracic tumors.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of hemophagocytic syndrome as an immune-related adverse event in malignant thoracic tumors.
Key secondary outcomes
Clinical characteristics, treatment course, prognosis, and therapeutic efficacy of immune checkpoint inhibitors in patients who developed hemophagocytic syndrome.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key 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
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Gon |
Organization
Nihon University School of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine
Zip code
173-8610
Address
30-1 Ohyaguchi-Kamimachi, Itabashi, Tokyo 173-8610, Japan
TEL
03-3972-8111
gon.yasuhiro@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Iida |
Organization
Nihon University School of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine
Zip code
173-8610
Address
30-1 Ohyaguchi-Kamimachi, Itabashi, Tokyo 173-8610, Japan
TEL
03-3972-8111
Homepage URL
iida.yuko@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Itabashi Hospital, Clinical Research Judging Committee
Address
30-1 Ohyaguchi-Kamimachi, Itabashi, Tokyo 173-8610, Japan
Tel
0339728111
med.rinsyokenkyu@nihon-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
35
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study is ongoing.
Management information
Registered date
| 2026 | Year | 05 | Month | 13 | Day |
Last modified on
| 2026 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070423
