UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016554 |
|---|---|
| Receipt number | R000019211 |
| Scientific Title | Prospective trial to investigate whether white opaque substance as visualized is present in colonic hyper plastic polyps by magnifying endoscopy with narrow-band-imaging |
| Date of disclosure of the study information | 2015/02/16 |
| Last modified on | 2015/11/27 10:00:25 |
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Basic information
Public title
Prospective trial to investigate whether white opaque substance as visualized is present in colonic hyper plastic polyps by magnifying endoscopy with narrow-band-imaging
Acronym
White opaque substance study of colorectal hyper plastic polyp
Scientific Title
Prospective trial to investigate whether white opaque substance as visualized is present in colonic hyper plastic polyps by magnifying endoscopy with narrow-band-imaging
Scientific Title:Acronym
White opaque substance study of colorectal hyper plastic polyp
Region
| Japan |
Condition
Condition
Colorectal hyperplastic polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether white opaque substance, which obscure microvessels, is present in hyper plastic polyps
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 white opaque substance, which obscure microvessels, is present in hyper plastic polyps
Key secondary outcomes
Histological investigation of clinical findings
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
1.The patient's age is equal to or than.
2.The patients whose ECOG performance status should be 0 or 1.
3.The patients who gave written informed consent.
Key exclusion criteria
1.Lesion pathologically diagnosed epithelial or non-epithelial tumor.
2.Patients with inflammatory bowel disease.
3.The patients with past history of colorectal surgery.
4.The patients with serious underlying disorder.
5.The lesion with erosion, ulceration or inappropriate to participate in the endoscopic observation.
6.Patients who were determined to be inappropriate to participate in the study because of severe mental disorder.
7.The patients that were determined to be inappropriate to participate in the study by the investigate.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenshi yao |
Organization
Fukuoka University Chikushi Hospital
Division name
Depertment of Endoscopy
Zip code
Address
1-1-1 Zokumyoin Chikusjhino-city Fukuoka
TEL
092-921-1011
ishiharanoyoume@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi ishihara |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-1-1 Zokumyoin Chikusjhino-city Fukuoka
TEL
090-2512-7479
Homepage URL
ishiharanoyoume@gmail.com
Sponsor or person
Institute
Fukuoka University Central Research Institute for Endoscopy
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University Central Research 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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 01 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
total case number of ninety seven
Management information
Registered date
| 2015 | Year | 02 | Month | 16 | Day |
Last modified on
| 2015 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019211
