UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of diagnostic ability for ulcerative colitis-associated colorectal dysplasia (UCAD) by using Endocytoscopy
Acronym	Evaluation of diagnostic ability for ulcerative colitis-associated colorectal dysplasia (UCAD) by using Endocytoscopy
Scientific Title	Evaluation of diagnostic ability for ulcerative colitis-associated colorectal dysplasia (UCAD) by using Endocytoscopy
Scientific Title:Acronym	Evaluation of diagnostic ability for ulcerative colitis-associated colorectal dysplasia (UCAD) by using Endocytoscopy
Region	Japan

Condition
Condition	colitis-associated colorectal dysplasia (UCAD)
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the diagnostic ability of Endocytoscopy in ulcerative colitis-associated tumor
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Qualitative diagnostic ability of ulcerative colitis-associated tumor
Key secondary outcomes	Compare the diagnosis of the disease range of ulcerative colitis-associated tumor with pathological results

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	# Patients with consent by document # Patients who are over 20 years old when the patients consent # Patients with previously confirmed histopathological diagnosis of ulcerative colitis-associated tumor # Patients with suspected ulcerative colitis-associated tumor
Key exclusion criteria	# Patients who are judged as inappropriate by investigator # Patients without the self judgement abilities
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Takeshi Middle name Last name Yamamura
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	466-8550
Address	65, Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL	052-741-2172
Email	tyamamu@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Issei Middle name Last name Hasegawa
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	466-8550
Address	65, Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL	052-741-2172
Homepage URL
Email	issei@med.nagoya-u.ac.jp

Sponsor
Institute	Department of Endoscopy, Nagoya University Hospital
Institute
Department

Funding Source
Organization	None
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	Nagoya University Hospital Ethics Review Committee
Address	65, Tsurumai-cho, Showa-ku, Nagoya, Japan
Tel	052-741-2172
Email	tyamamu@med.nagoya-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	2019 Year 11 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
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	Open public recruiting
Date of protocol fixation	2018 Year 07 Month 01 Day
Date of IRB	2018 Year 12 Month 14 Day
Anticipated trial start date	2019 Year 11 Month 12 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This observational study examines the diagnostic ability of Endocytoscopy in ulcerative colitis-associated colorectal dysplasia(UCAD)

Management information
Registered date	2019 Year 11 Month 11 Day
Last modified on	2021 Year 02 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043910