UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056911 |
|---|---|
| Receipt number | R000063021 |
| Scientific Title | Analysis of neutrophil-related biomarkers in digestive diseases |
| Date of disclosure of the study information | 2025/02/03 |
| Last modified on | 2026/02/04 09:50:29 |
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Basic information
Public title
Analysis of neutrophil-related biomarkers in digestive diseases
Acronym
Analysis of neutrophil-related biomarkers in digestive diseases
Scientific Title
Analysis of neutrophil-related biomarkers in digestive diseases
Scientific Title:Acronym
Analysis of neutrophil-related biomarkers in digestive diseases
Region
| Japan |
Condition
Condition
Sepsis (associated with digestive disease), liver dysfunction, cholangitis, pancreatitis, inflammatory bowel disease, hepatocellular carcinoma, polyps (indication for endoscopic resection)
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to discover what clinical information about the targeted digestive diseases is associated with neutrophil-related biomarkers and to find the impact of neutrophils in each disease.
Basic objectives2
Others
Basic objectives -Others
This study will elucidate the role of neutrophils in the target disease and find novel biomarkers and new therapeutic targets.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation or association between severity of each disease and neutrophil-related biomarkers.
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects who are hospitalized in our department and have the target disease will be recruited by explaining the study contents using a consent form and obtaining consent to participate in the study.
However, if the subject withdraws consent, the study will be terminated.
To minimize selection bias, we will obtain consent to participate and collect samples as consecutively as possible from the time the study begins.
Key exclusion criteria
none in particular
Target sample size
384
Research contact person
Name of lead principal investigator
| 1st name | Noriyoshi |
| Middle name | |
| Last name | Ogino |
Organization
University of Occupational and Environmental Health, Japan
Division name
3rd Internal Medicine
Zip code
807-8555
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka, Japan
TEL
093-691-7437
n-ogino@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriyoshi |
| Middle name | |
| Last name | Ogino |
Organization
University of Occupational and Environmental Health, Japan
Division name
3rd Internal Medicine
Zip code
807-8555
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka, Japan
TEL
093-691-7437
Homepage URL
n-ogino@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Occupational and Environmental Health, Japan
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka 807-8555, Japan
Tel
093-691-7437
n-ogino@med.uoeh-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
| 2025 | Year | 02 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 03 | 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
Non-intervention, single-center, prospective observational study
Management information
Registered date
| 2025 | Year | 02 | Month | 03 | Day |
Last modified on
| 2026 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063021
