UMIN-CTR Clinical Trial

Basic information
Public title	Diagnostic ulcerative colitis assosiated neoplasia with endocytoscopy
Acronym	EC-UCAN
Scientific Title	Diagnostic ulcerative colitis assosiated neoplasia with endocytoscopy
Scientific Title:Acronym	EC-UCAN
Region	Japan

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

Objectives
Narrative objectives1	The aim of this retrospective study was to demonstrate the diagnostic ability of combined EC irregularly-formed nuclei with PIT (EC-IN-PIT)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We evaluated and compared the diagnostic abilities of PIT alone and EC-IN-PIT.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients with UC whose lesions were observed by EC at the Showa University Northern Yokohama Hospital between February 2007 and April 2020.
Key exclusion criteria	Exclusion criteria were lesions histologically diagnosed as sporadic neoplasia, nondifferentiable lesions between UCAN and sporadic neoplasia, and nondifferentiable lesions between neoplasia and non-neoplasia.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Shin-ei Middle name Last name Kudo
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive Disease Center
Zip code	224-8503
Address	35-1 Chigasakichuo Tuduki-ku Yokohama
TEL	0459497000
Email	kudos@med.showa-u.ac.jp

Public contact
Name of contact person	1st name Yasuharu Middle name Wakamura Last name Maeda
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive Disease Center
Zip code	224-8503
Address	35-1 Chigasakichuo Tuduki-ku Yokohama
TEL	0459497000
Homepage URL
Email	yasuharumaeda610@hotmail.com

Sponsor
Institute	Digestive Disease Center, Showa University Northern Yokohama Hospital
Institute
Department

Funding Source
Organization	JSPS KAKENHI
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Showa University Northern Yokohama Hospital IRB
Address	35-1 Chigasakichuo Tuduki-ku
Tel	+81459497000
Email	irb02syh@ofc.showa-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 06 Month 12 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	103
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	2020 Year 05 Month 05 Day
Date of IRB	2020 Year 06 Month 12 Day
Anticipated trial start date	2020 Year 05 Month 15 Day
Last follow-up date	2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	First Strategy: PIT alone diagnosis. Second Strategy: EC-IN-PIT (combined EC irregular nuclei with PIT) diagnosis:

Management information
Registered date	2020 Year 06 Month 09 Day
Last modified on	2020 Year 06 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046456