UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011220 |
|---|---|
| Receipt number | 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 11:32:04 |
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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
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
kentaro2316@live.jp
Sponsor or person
Institute
Fukuoka University Central Research Institute for Endoscopy
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013101
