UMIN-CTR Clinical Trial

Basic information
Public title	Discovery study of biomarkers of small bowel lesion in Crohn's disease
Acronym	Biomarkers of small bowel Crohn's disease
Scientific Title	Discovery study of biomarkers of small bowel lesion in Crohn's disease by proteome analysis
Scientific Title:Acronym	ProSBoC study
Region	Japan

Condition
Condition	Crohn's disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Patients with Crohn's ileitis are often asymptomatic and show no inflammation in blood test. In this study, we performed proteome analysis using plasma in addition to blood markers including CBC, ESR, CRP, LRG, albumin levels, and fecal calprotectin before and 6 months after intensified medical treatment for active Crohn's small bowel lesions.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Improvement of each biomarker 6 months after intensified medical treatment
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	4 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	patients with active Crohn's small bowel lesions
Key exclusion criteria	patients who cannot undergo double-balloon enteroscopy due to bad health condition
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Naoki Middle name Last name Ohmiya
Organization	Fujita Health University
Division name	Department of advanced Endoscopy
Zip code	470-1192
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL	0562-93-9240
Email	nohmiya@fujita-hu.ac.jp

Public contact
Name of contact person	1st name Keiko Middle name Last name Uesugi
Organization	Fujita Health University School of Medicine
Division name	IRB
Zip code	470-1192
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL	0562-93-2860
Homepage URL
Email	research@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University, Department of Advanced Endoscopy, Department of Gastroenterology
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	Fujita Health University School of Medicine, IRB
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
Tel	0562-93-2860
Email	research@fujita-hu.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	藤田医科大学病院（愛知県）

Other administrative information
Date of disclosure of the study information	2021 Year 06 Month 29 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	0
Results	Ongoing
Results date posted	2021 Year 06 Month 29 Day
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 06 Month 29 Day
Date of IRB	2015 Year 09 Month 25 Day
Anticipated trial start date	2021 Year 06 Month 29 Day
Last follow-up date	2023 Year 06 Month 30 Day
Date of closure to data entry	2026 Year 07 Month 31 Day
Date trial data considered complete	2026 Year 08 Month 31 Day
Date analysis concluded	2026 Year 12 Month 31 Day

Other
Other related information	None

Management information
Registered date	2021 Year 06 Month 29 Day
Last modified on	2021 Year 06 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051051