UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046284 |
|---|---|
| Receipt number | R000052814 |
| Scientific Title | Investigation of predictive factors for therapeutic efficacy of immunosuppressive therapy for inflammatory bowel disease using machine learning |
| Date of disclosure of the study information | 2021/12/20 |
| Last modified on | 2022/03/24 20:31:25 |
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Basic information
Public title
Investigation of predictive factors for therapeutic efficacy of immunosuppressive therapy for inflammatory bowel disease using machine learning
Acronym
Investigation of predictive factors for therapeutic efficacy of immunosuppressive therapy for inflammatory bowel disease using machine learning
Scientific Title
Investigation of predictive factors for therapeutic efficacy of immunosuppressive therapy for inflammatory bowel disease using machine learning
Scientific Title:Acronym
Investigation of predictive factors for therapeutic efficacy of immunosuppressive therapy for inflammatory bowel disease using machine learning
Region
| Japan |
Condition
Condition
Inflammatory bowel disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate predictive biomarkers for the therapeutic efficacy of immunosuppressive therapy for inflammatory bowel disease using statistical methods as well as machine learning.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
This observational study investigates biomarkers that are useful for predicting the therapeutic efficacy of immunosuppressive therapy for inflammatory bowel disease.
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
This study includes patients with inflammatory bowel diseases who started immunosuppressive therapy at the Department of Gastroenterology and Hepatology, Kyorin University Hospital.
The diagnosis of ulcerative colitis and Crohn's disease is made following the guideline by the Japanese Inflammatory Bowel Disease Research Group affiliated with the Japan Ministry of Heath, Labour and Welfare.
Key exclusion criteria
Patients who don't consent to this study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Miyoshi |
Organization
Kyorin University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
181-8611
Address
Shinkawa 6-20-2, Mitaka-shi, Tokyo
TEL
0422-47-5511
jmiyoshi@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Miyoshi |
Organization
Kyorin University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
181-8611
Address
Shinkawa 6-20-2, Mitaka-shi, Tokyo
TEL
0422-47-5511
Homepage URL
jmiyoshi@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
The Ethics Committee of Kyorin University School of Medicine
Address
Shinkawa 6-20-2, Mitaka-shi, Tokyo
Tel
0422-47-5511
rec@ks.kyorin-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
| 2021 | Year | 12 | Month | 20 | 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
| 2021 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The clinical information obtained from Kyorin University Hospital medical record system includes sex, age, diagnosis, past history, history of IBD, blood examinations, endoscopic findings, imaging tests. The residue of blood examinations is used to examine the levels of cytokines, drug trough concentration, the concentrations of anti-drug antibodies, and to perform metabolomics analyses.
Management information
Registered date
| 2021 | Year | 12 | Month | 05 | Day |
Last modified on
| 2022 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052814
