UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011220
Receipt No. R000013101
Scientific Title Prospective trial to investigate the nature of white opaque substance in colonic epithelial neoplasia as visualized by magnifying endoscopy with narrow-band imaging.
Date of disclosure of the study information 2013/07/18
Last modified on 2015/01/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Prospective trial to investigate the nature of white opaque substance in colonic epithelial neoplasia as visualized by magnifying endoscopy with narrow-band imaging.
Acronym Colonic WOS study
Scientific Title Prospective trial to investigate the nature of white opaque substance in colonic epithelial neoplasia as visualized by magnifying endoscopy with narrow-band imaging.
Scientific Title:Acronym Colonic WOS study
Region
Japan

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

Objectives
Narrative objectives1 To investigate whether or not WOS within the superficial part of the colonic neoplasia comprised of the lipid droplets.
Basic objectives2 Others
Basic objectives -Others HIstological investigation of clinical findings
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To investigate whether or not the presence of WOS within the superficial part of the colonic neoplasia is correlated with the presence of lipid droplets in the histological specimen.
Key secondary outcomes

Base
Study type

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

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Magnifying colonoscopy with narrow-band imaging
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 1. The patients with colonic cancer or adenoma which were subjected to endoscopic resection (polypectomy or EMR).
2. The patients whose ECOG performance status should be 0 or 1.
3. The patients with age or more 20 years old.
4. The patients who gave written informed consent
Key exclusion criteria 1. The neoplasias with erosion, ulceration or bleeding which disturb the endoscopic observation of surface morphology
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
Target sample size 75

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenshi yao
Organization Fukuoka University Chikushi Hospital
Division name Department of Endoscopy
Zip code
Address 1-1-1 Zokumyoin Chikushino-city Fukuoka
TEL 092-921-1011
Email kentaro2316@live.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro imamura
Organization Fukuoka University Chikushi Hospital
Division name Department of Gastroenterology
Zip code
Address 1-1-1 Zokumyoin Chikushino-city Fukuoka
TEL 090-8413-8001
Homepage URL
Email kentaro2316@live.jp

Sponsor
Institute Fukuoka University Central Research Institute for Endoscopy
Institute
Department

Funding Source
Organization Fukuoka University Central Institute for Endoscopy
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
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 福岡大学筑紫病院

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 18 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
2013 Year 03 Month 27 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 07 Month 18 Day
Last modified on
2015 Year 01 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013101

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.