UMIN-CTR Clinical Trial

Basic information
Public title	Validation of Dual red imaging score (DRI score) to evaluate the severity of ulcerative colitis
Acronym	Validation of DRI score
Scientific Title	Validation of Dual red imaging score (DRI score) to evaluate the severity of ulcerative colitis
Scientific Title:Acronym	Validation of DRI score
Region	Japan

Condition
Condition	Ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In recent years, image-enhanced endoscopy has been reported the usefulness to evaluate disease activity of UC. Dual red imaging (DRI) is a new imaging technology has been introduced that uses 3 wavelengths for illumination: 540nm, 600nm and 630nm. DRI was closely correlated with both the endoscopic and the histological grades, and developed the DRI score. However, no study has validated DRI score and not actually used in real world. Therefore, the aim of this study is to validate DRI score prospectively.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The Mayo endoscopic scores, UCEIS, DRI scores, and histologic scores were evaluated.
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	18 years-old <
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	UC patients whom colonoscopy was scheduled between May and October 2019 at Gunma University Hospital
Key exclusion criteria	Patients with severe or fulminant disease were excluded. We also excluded patients who cannot deny of mucosal cytomegalovirus infection and coexistence of infectious colitis.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Toshio Middle name Last name Uraoka
Organization	Gunma University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	371-8511
Address	3-39-15 Showa-machi Maebashi, Gunma
TEL	0272208137
Email	uraoka@gunma-u.ac.jp

Public contact
Name of contact person	1st name Yu Middle name Last name Hashimoto
Organization	Gunma University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	371-8511
Address	3-39-15 Showa-machi Maebashi, Gunma
TEL	0272208137
Homepage URL
Email	y_hashi@gunma-u.ac.jp

Sponsor
Institute	Gunma University Graduate School of Medicine
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	Gunma University Ethical Review Board for Medical Research Involving Human Subjects
Address	3-39-15 Showa-machi Maebashi, Gunma
Tel	0272208137
Email	hitotaisho-ciru@ml.gunma-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	2020 Year 09 Month 15 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	12
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	No longer recruiting
Date of protocol fixation	2019 Year 04 Month 15 Day
Date of IRB	2019 Year 05 Month 08 Day
Anticipated trial start date	2019 Year 05 Month 08 Day
Last follow-up date	2019 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The colorectum was divided into six segments (cecum, ascending colon, transverse colon, descending colon, sigmoid colon, and rectum). For each segment we use the White light imaging (WLI) mode to evaluate UC activity, and the imaging mode was switched to DRI to evaluate it

Management information
Registered date	2020 Year 09 Month 10 Day
Last modified on	2020 Year 09 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047514