UMIN-CTR Clinical Trial

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
Email	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
Email	jmiyoshi@ks.kyorin-u.ac.jp

Sponsor
Institute	Kyorin University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052814