UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of activity and prediction of relapse by endoscopic vascular scoring in patients with ulcerative colitis
Acronym	vascular scoring in ulcerative colitis
Scientific Title	Evaluation of activity and prediction of relapse by endoscopic vascular scoring in patients with ulcerative colitis
Scientific Title:Acronym	vascular scoring in ulcerative colitis
Region	Japan

Condition
Condition	ulcerative colitis
Classification by specialty	Gastroenterology Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation the ulitiliy of vascular scoring compring with UCEIS, Baron score and Mayo score
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation with vascular scoring and stool calprotectin concentration Correlation with vascular scoring and relapse rate in one year
Key secondary outcomes	Correlation with vascular scoring and stool hemoglobin concentration Correlation with Baron scores and stool hemoglobin or calprotectin concentration Correlation with UCEIS and stool hemoglobin or calprotectin concentration Correlation with mayo score and stool hemoglobin or calprotectin concentration

Base
Study type

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	evaluation of vascular scoring by colonoscopy
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	15 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who will be able to be examined by colonoscopy Patients who has informed consent
Key exclusion criteria	Patients who will not be able to be examined by colonoscopy Patient in pregnant and lactate state Patients who has not informed consent Patients who has or has been treated malignancy Patients with colectomy
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Shingo Kato
Organization	Saitama Medical Center
Division name	Gastroenterology and Hepatology
Zip code
Address	1981, Kamoda, Kawagoe City, Japan
TEL	049-228-3564
Email	skato@saitama-med.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Shingo Kato
Organization	Saitama Medical Center
Division name	Gastroenterology and hepatology
Zip code
Address	1981, Kamoda, Kawagoe City, Japan
TEL	049-2228-3564
Homepage URL
Email	skato@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University
Institute
Department

Funding Source
Organization	Saitama Medical University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2014 Year 05 Month 01 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	176
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	Completed
Date of protocol fixation	2014 Year 04 Month 30 Day
Date of IRB
Anticipated trial start date	2014 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 04 Month 02 Day
Last modified on	2019 Year 03 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015892