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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041750
Receipt No. R000047514
Scientific Title Validation of Dual red imaging score (DRI score) to evaluate the severity of ulcerative colitis
Date of disclosure of the study information 2020/09/15
Last modified on 2020/09/10

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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

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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