UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061862 |
|---|---|
| Receipt number | R000069237 |
| Scientific Title | An Exploratory Prospective Observational Study on the Involvement of Neutrophil-Derived Factors in the Pathogenesis of Sepsis |
| Date of disclosure of the study information | 2026/06/12 |
| Last modified on | 2026/06/10 23:07:53 |
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Basic information
Public title
An Exploratory Prospective Observational Study on the Involvement of Neutrophil-Derived Factors in the Pathogenesis of Sepsis
Acronym
A Prospective Observational Study Investigating the Role of Neutrophils in the Pathogenesis of Sepsis
Scientific Title
An Exploratory Prospective Observational Study on the Involvement of Neutrophil-Derived Factors in the Pathogenesis of Sepsis
Scientific Title:Acronym
A Prospective Observational Study Investigating the Role of Neutrophils in the Pathogenesis of Sepsis
Region
| Japan |
Condition
Condition
Sepsis
Classification by specialty
| Medicine in general | Infectious disease | Emergency medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This exploratory study aims to investigate how structural changes in neutrophils and neutrophil-derived factors contribute to the pathogenesis of sepsis.
Basic objectives2
Others
Basic objectives -Others
Investigation of Factors Influencing Structural and Functional Changes in Neutrophils in Healthy Individuals
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association of Sepsis Severity With Neutrophil Morphological Changes and Histone Modifications, Including Citrullination, Methylation, and Acetylation
Key secondary outcomes
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) Adults aged 18 years or older.
2) Patients who are clinically suspected of having an infectious disease and are classified as an intermediate-risk group according to the National Early Warning Score 2 (NEWS2), defined as a total NEWS2 score of 5 points or higher or a score of 3 points in any single parameter.
3) Healthy controls are defined as individuals with no history of chronic diseases or malignancies, who are not currently receiving medical treatment on an outpatient basis, who do not smoke, and whose alcohol consumption is less than one serving of sake (approximately 180 mL) per day. Healthy volunteers will be recruited through posters displayed in Building 3 of the Faculty of Science, The University of Tokyo.
4) Patients or healthy controls from whom written informed consent for study participation has been obtained from the individual themselves or, when applicable, from their legally authorized representative.
Key exclusion criteria
1) Patients presenting with trauma.
2)Individuals deemed inappropriate for inclusion in the study by the investigator for any other reason.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yukiko |
| Middle name | |
| Last name | Iwasaki |
Organization
Saitama Medical University
Division name
Department of Rheumatology and Applied Immunology, Department of Palliative Medicine
Zip code
350-0495
Address
38 Morohongo, Moroyama-machi, Iruma-gun
TEL
+81-49-276-1705
yu_nyan@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Naito |
Organization
Saitama Medical University
Division name
Emergency Unit
Zip code
350-0495
Address
38 Morohongo, Moroyama-machi, Iruma-gun
TEL
+81-49-276-1111
Homepage URL
naito.yuusuke@1972.saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical 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
Institutional Review Board of the Saitama Medical University Hospital
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
Tel
+81-49-276-1111
hirb@saitama-med.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 | 06 | Month | 12 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 09 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 06 | Month | 10 | Day |
Last modified on
| 2026 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069237
