UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061401 |
|---|---|
| Receipt number | R000070257 |
| Scientific Title | Evaluation of the Utility of a Novel Nucleosome Biomarker Associated with Neutrophil Extracellular Traps |
| Date of disclosure of the study information | 2026/04/28 |
| Last modified on | 2026/04/28 13:30:30 |
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Basic information
Public title
Evaluation of the Utility of a Novel Nucleosome Biomarker Associated with Neutrophil Extracellular Traps
Acronym
NB-NET study
Scientific Title
Evaluation of the Utility of a Novel Nucleosome Biomarker Associated with Neutrophil Extracellular Traps
Scientific Title:Acronym
NB-NET study
Region
| Japan |
Condition
Condition
ANCA-associated vasculitis, Antiphospholipid syndrome, Sepsis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure plasma levels of nucleosomes that may reflect neutrophil extracellular trap (NET) formation and to evaluate their utility as NETs markers by comparison with the representative NETs marker, the MPO-DNA complex.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MPO-DNA complex
H3.1-nucleosome
H3R8cit-nucleosome
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with ANCA-associated vasculitis, anti- phospholipid syndrome, or sepsis.
Healthy adult volunteers
Key exclusion criteria
N/A
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Ishizu |
Organization
Faculty of Health Sciences, Hokkaido University
Division name
Department of Medical Laboratory Science
Zip code
060-0812
Address
Kita 12 Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL
011-706-3385
aishizu@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Sakiko |
| Middle name | |
| Last name | Masuda |
Organization
Faculty of Health Sciences, Hokkaido University
Division name
Department of Medical Laboratory Science
Zip code
060-0812
Address
Kita 12 Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL
011-706-3405
Homepage URL
sakikomasuda@hs.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
-
Address
-
Tel
-
-
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
北海道大学（北海道）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 28 | 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
40
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
Main results already published
Date of protocol fixation
| 2024 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2027 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is an observational study. All plasma samples were purchased from venders where informed consent of the donors were obtained at each supplier under approval by the ethics review broad. No additional human samples were collected, and no personally identifiable information was obtained; therefore, ethics approval by the institution review board is not required.
In this study, plasma nucleosome levels will be measured in each disease group and in healthy adults, and their association with the representative neutrophil extracellular trap (NET) marker, MPO-DNA complex, will be examined to evaluate their utility as NET markers.
Management information
Registered date
| 2026 | Year | 04 | Month | 28 | Day |
Last modified on
| 2026 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070257
