UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021167 |
|---|---|
| Receipt number | R000024264 |
| Scientific Title | Prospective trial to investigate the morphological features of the white opaque substance (WOS) in colorectal epithelial neoplasms |
| Date of disclosure of the study information | 2016/02/24 |
| Last modified on | 2020/02/26 09:59:11 |
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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
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
ky875416@yahoo.co.jp
Sponsor or person
Institute
Fukuoka University Chikushi Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024264
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
