UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041750
Receipt number 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 20:37:28

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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 or person

Institute

Gunma University Graduate School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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