UMIN-CTR Clinical Trial

Basic information
Public title	Chromoendoscopic method using an acetic acid indigocarmine mixture for diagnostic accuracy in delineating margin of colitic cancer.
Acronym	Chromoendoscopy of colitic cancer using an acetic acid indigocarmine mixture
Scientific Title	Chromoendoscopic method using an acetic acid indigocarmine mixture for diagnostic accuracy in delineating margin of colitic cancer.
Scientific Title:Acronym	Chromoendoscopy of colitic cancer using an acetic acid indigocarmine mixture
Region	Japan

Condition
Condition	patients with ulcerative colitis had high risk of colitic cancer. A:patients suspected dysplasia(low/high grade) or cancer. B:patients had plan of treatment of the dysplasia or cancer.
Classification by specialty	Medicine in general Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The primary aim of this study was to evaluate the usefulness of AIM for diagnosed colitic cancer.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The number of detected colitic cancer or dysplasia, comparison using white light between using AIM.
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	40mL AIM solution (0.6% acetic acid with 0.4% IC) was sprinkled onto the lesions and images were recorded.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Patients with ulcerative colitis(UC) in clinical remission. 2.Patients visits within a year. 3.Patients who have underwent colonoscopy as UC surveillance. 4.Patients with UC in remission (Mayo score <2) 5.Patients had dysplasia or/and cancer. 6.Patient age is 20 years of age 7.Patients with informed consent.
Key exclusion criteria	1.Patients with a history that has received the surgical operation of UC. 2.Pregnant patients. 3.Patients who are breast-feeding. 4.Patients who have been the administration of the other study drug or investigational drugs within three months before the start of the administration of the study drug. 5.Patients has determined that inappropriate by principal investigator.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Sakiko Hiraoka
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Gastroenterology and Hepatology
Zip code
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	086-235-7219
Email	sakikoh@cc.okayama-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name YuusakuSugihara
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Gastroenterology and Hepatology
Zip code
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	086-235-7219
Homepage URL
Email	y.sugi117@gmail.com

Sponsor
Institute	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
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	2016 Year 03 Month 13 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	Completed
Date of protocol fixation	2015 Year 10 Month 20 Day
Date of IRB	2020 Year 11 Month 07 Day
Anticipated trial start date	2015 Year 10 Month 20 Day
Last follow-up date	2020 Year 11 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 03 Month 13 Day
Last modified on	2020 Year 11 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024710