UMIN-CTR Clinical Trial

Basic information
Public title	The new diagnosis method using nanobecon for colitis associated carcinoma
Acronym	The new diagnosis method for colitis associated carcinoma
Scientific Title	The new diagnosis method using nanobecon for colitis associated carcinoma
Scientific Title:Acronym	The new diagnosis method for colitis associated carcinoma
Region	Japan

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

Objectives
Narrative objectives1	The efficacy of new diagnosis method using nanobecon for colitis associated carcinoma
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The efficacy of new diagnosis method using nanobecon for colitis associated carcinoma
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Conventional historogical examaination
Interventions/Control_2	New immunohistochemisty using nanobecon
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	Patients with colon carcinoma or ulcerative colitis
Key exclusion criteria	1.Patients with severe ulcerative colitis 2.Patients concomitant with severe infection, heart failure, hepatic disorder, pulmonary disease, or CNS disease 3.Pregnant woman 4.Patients who did not agree with this study 5.Patients that physician determined inappropriate
Target sample size	34

Research contact person
Last name of lead principal investigator	1st name Hiroshi Middle name Last name Nakase
Organization	Kyoto Univeristy Hospital
Division name	Gastroenterology and Hepatology
Zip code	606-8507
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city, Kyoto, Japan
TEL	075-751-4319
Email	hiropy_n@kuhp.kyoto-u.ac.jp

Public contact
1st name of contact person	1st name Takuya Middle name Last name Yoshino
Organization	Kyoto Univeristy Hospital
Division name	Gastroenterology and Hepatology
Zip code	606-8507
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city, Kyoto, Japan
TEL	075-751-4319
Homepage URL
Email	tyocci@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology, Kyoto Univeristy Hospital
Institute
Department

Funding Source
Organization	ADEKA Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of pharmacy, Setsunan University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Institutional Review Board of Kyoto University Hospital
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city, Kyoto, Japan
Tel	0757534680
Email	ethcom@kuhp.kyoto-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	2014 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://www.sciencedirect.com/science/article/abs/pii/S093964111830883X?via%3Dihub
Number of participants that the trial has enrolled	0
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 10 Month 20 Day
Date of IRB	2015 Year 01 Month 19 Day
Anticipated trial start date	2014 Year 11 Month 15 Day
Last follow-up date	2018 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 10 Month 21 Day
Last modified on	2019 Year 04 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017999