UMIN-CTR Clinical Trial

Basic information
Public title	Prospective trial to investigate the morphological features of the white opaque substance (WOS) in colorectal epithelial neoplasms
Acronym	Prospective trial to investigate the morphological features of the WOS in colorectal epithelial neoplasms
Scientific Title	Prospective trial to investigate the morphological features of the white opaque substance (WOS) in colorectal epithelial neoplasms
Scientific Title:Acronym	Prospective trial to investigate the morphological features of the WOS in colorectal epithelial neoplasms
Region	Japan

Condition
Condition	Colorectal epithelial neoplasia
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate the diagnostic performance of white opaque substance (WOS) for the diagnosis of colorectal neoplasm.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The frequency of colorectal neoplasm with regular/irregular WOS
Key secondary outcomes	To investigate the depth and clinicopathological characteristics between WOS-negative/regular WOS-positive/irregular WOS-positive

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	The patients with early colorectal cancer or adenoma which were subjected to endoscopic resection or surgery.
Key exclusion criteria	1. The neoplasias with erosion, ulceration or bleeding which disturb the endoscopic observation 2. The patients with serious underlying disorders 3. The patients with past history of colectomy 4. The patients that were determined to be inappropriate to participate in the study by the investigators 5. The patients wih inflammatory bowel disease 6. The patients with familial adenomatous polyposis 7. The patients with advanced colonic cancer
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Hisabe
Organization	Fukuoka University Chikushi Hospital
Division name	Department of Gastroenterology
Zip code	818-0582
Address	1-1-1 Zokumyoin Chikushino-city Fukuoka
TEL	092-921-1011
Email	ky875416@yahoo.co.jp

Public contact
Name of contact person	1st name Kazutomo Middle name Last name Yamasaki
Organization	Fukuoka University Chikushi Hospital
Division name	Department of Gastroenterology
Zip code	818-8502
Address	1-1-1 Zokumyoin Chikushino-city Fukuoka
TEL	080-3974-4626
Homepage URL
Email	ky875416@yahoo.co.jp

Sponsor
Institute	Fukuoka University Chikushi Hospital
Institute
Department

Funding Source
Organization	Fukuoka University Chikushi Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Fukuoka University Chikushi Hospital
Address	1-1-1 Zokumyoin Chikushino-city Fukuoka
Tel	092-921-1011
Email	ky875416@yahoo.co.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	福岡大学筑紫病院

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 24 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	Preinitiation
Date of protocol fixation	2016 Year 01 Month 16 Day
Date of IRB
Anticipated trial start date	2016 Year 02 Month 24 Day
Last follow-up date	2016 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Participants were performed colonoscopy with magnifying NBI before therapy. The presence or absence of WOS in the lesion was investigated. In the case of WOS-positive, whether it is regular or irregular was assessed.

Management information
Registered date	2016 Year 02 Month 23 Day
Last modified on	2020 Year 02 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024264