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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044695
Receipt No. R000051051
Scientific Title Discovery study of biomarkers of small bowel lesion in Crohn's disease by proteome analysis
Date of disclosure of the study information 2021/06/29
Last modified on 2021/06/29

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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