UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of serum biomarker for prediction of efficacy of the treatments for inflammatory bowel disease
Acronym	Biomarker for IBD
Scientific Title	Investigation of serum biomarker for prediction of efficacy of the treatments for inflammatory bowel disease
Scientific Title:Acronym	Biomarker for IBD
Region	Japan

Condition
Condition	Inflammatory bowel diseases(ulcerative colitis, crohn's disease), intestinal Behcet disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness of oligosaccharide analysis of immunoglobulins and cytokines for the biomarkers for the efficacy of biologics in patients with inflammatory bowel diseases
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The titers of biomarkers(serum oligosaccharides in immunoglobulins and cytokines)
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients with inflammatory bowel diseases(ulcerative colitis, Crohn's disease), Behcet disease 2)Patients who will use or are using biologics (infliximab and adalimumab)
Key exclusion criteria	1) Patients with mental diseases 2) Patients younger than 16 years old. 3) Patients who are not suitable to attend this study judged by physicians.
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Hideki Middle name Last name Iijima
Organization	Osaka University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	565-0871
Address	2-15 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL	+81-6-6879-3621
Email	hiijima@gh.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Hideki Middle name Last name Iijima
Organization	Osaka University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	565-0871
Address	2-15 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL	+81-6-6879-3621
Homepage URL
Email	hiijima@gh.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Osaka University Graduate School of Medicine
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	Osaka University
Address	2-2 Yamadaoka, Suita, Osaka
Tel	06-6879-3621
Email	hiijima@gh.med.osaka-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	2014 Year 06 Month 06 Day

Related information
URL releasing protocol	https://academic.oup.com/ecco-jcc/article/11/1/84/2631824
Publication of results	Published

Result
URL related to results and publications	https://academic.oup.com/ecco-jcc/article/11/1/84/2631824
Number of participants that the trial has enrolled	129
Results	In patients with inflammatory bowel diseases (IBD), alterations of oligosaccharide structures of IgA or IgG can serve as diagnostic biomarkers of IBD. Serum leucine-rich alpha-2 glycoprotein was associated with clinical and endoscopic activity of IBD and can serve as a new biomarker for monitoring disease activity of IBD.
Results date posted	2020 Year 12 Month 10 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2016 Year 11 Month 13 Day
Baseline Characteristics	129 patients with ulcerative coltis
Participant flow	Written informed consent was obtained from out or hospitalized ulcerative colitis patients and serum samples and clinical data were obtained from these patients.
Adverse events	N/A
Outcome measures	Correlation of serum LRG and clinical or endoscopic activity of inflammatory bowel disease.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 01 Day
Date of IRB	2014 Year 05 Month 07 Day
Anticipated trial start date	2014 Year 06 Month 01 Day
Last follow-up date	2019 Year 06 Month 13 Day
Date of closure to data entry	2019 Year 06 Month 13 Day
Date trial data considered complete	2019 Year 06 Month 13 Day
Date analysis concluded	2019 Year 06 Month 13 Day

Other
Other related information	Serum samples from the patients treated with biologics will be analyzed for biomarkers.

Management information
Registered date	2014 Year 06 Month 06 Day
Last modified on	2020 Year 12 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016517