UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047496 |
|---|---|
| Receipt number | R000053529 |
| Scientific Title | Validation of the usefulness of ORAIP as an IBD biomarker |
| Date of disclosure of the study information | 2022/04/30 |
| Last modified on | 2025/04/17 09:45:54 |
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Basic information
Public title
Investigation of the usefulness of Oxidative stress-Responsive Apoptosis Inducing Protein (ORAIP) as a biomarker for inflammatory bowel disease (IBD)
Acronym
ORAIP biomarker study
Scientific Title
Validation of the usefulness of ORAIP as an IBD biomarker
Scientific Title:Acronym
ORAIP biomarker study
Region
| Japan |
Condition
Condition
Inflammatory bowel disease
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will measure ORAIP concentrations in the peripheral blood of IBD patients, investigate the correlation between disease activity and ORAIP concentrations, and search for the possibility that blood ORAIP concentrations may be a biomarker of IBD activity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between disease activity and blood ORAIP levels
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients who meet the following conditions will be included.
(1) Patients with inflammatory bowel disease (mild to severe)
2) Adult
(3) Any gender
(4)Both inpatients and outpatients are included.
(5) Patients who have given their free and voluntary consent to participate in this study.
Key exclusion criteria
The following patients will be excluded from the standpoint of ensuring safety.
(1) All patients with hepatic disease, renal disease, cardiac disease, or other serious complications that are judged to be inappropriate by the physician in charge.
(2) Patients with other autoimmune diseases
2) Patients with other autoimmune diseases.
3) Patients taking antithrombotic medication
(3) Patients taking anti-thrombotic drugs (4) Lactating mothers, pregnant women, and those who may be pregnant
(5) Other patients deemed unsuitable by the physician.
Translated with www.DeepL.com/Translator (free version)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomoyoshi |
| Middle name | |
| Last name | Shibuya |
Organization
Juntendo University
Division name
Gastroenterology
Zip code
113-8421
Address
2-1-1 Hongo Bunkyo-ku
TEL
03-3813-3111
tomoyosi@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyoshi |
| Middle name | |
| Last name | Shibuya |
Organization
Juntendo University
Division name
Gastroenterology
Zip code
113-8421
Address
2-1-1 Hongo Bunkyo-ku
TEL
03-3813-3111
Homepage URL
tomoyosi@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
non
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
Juntendo University
Address
2-1-1 Hongo Bunkyo-ku Tokyo Japan
Tel
03-3814-5672
jcrtc_operation@juntendo.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
| 2022 | Year | 04 | Month | 30 | 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
| 2022 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | 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
Management information
Registered date
| 2022 | Year | 04 | Month | 15 | Day |
Last modified on
| 2025 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053529
