UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017599 |
|---|---|
| Receipt number | R000019366 |
| Scientific Title | Usefulness of Linked Color Image(LCI)in surveillance colonoscopy of the patients with SSA/P in the colon |
| Date of disclosure of the study information | 2015/05/18 |
| Last modified on | 2015/05/18 08:39:25 |
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Basic information
Public title
Usefulness of Linked Color Image(LCI)in surveillance colonoscopy of the patients with SSA/P in the colon
Acronym
Usefulness of Linked Color Image(LCI)in surveillance colonoscopy of the patients with SSA/P in the colon
Scientific Title
Usefulness of Linked Color Image(LCI)in surveillance colonoscopy of the patients with SSA/P in the colon
Scientific Title:Acronym
Usefulness of Linked Color Image(LCI)in surveillance colonoscopy of the patients with SSA/P in the colon
Region
| Japan |
Condition
Condition
A person to have one or more SSA/P diagnosed histopathologically. (Those are endoscopically resected, or those that are not resected)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify if LCI mode of the laser endoscopy is superior to white light endoscopy in detection of new SSA/P in patients with known SSA/P and those underwent endoscopic resection of SSA/P.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Detection rate of SSA/P
Key secondary outcomes
Base
Study type
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Blinding
Open -no one is 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
colonoscopy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A person to have one or more SSA/P diagnosed histopathologically (endoscopically resected, or those are not resected). Age, gender does not matter.
Key exclusion criteria
1) A person who underwent colectomy except appendectomy
2) Those who are taking anti-thrombotic agents such as, Aspirin, Ticlopidine, Hydrochloride, Warfarin potassium, Dipyridamole.
3) In cases that informed consent could not be obtained to participate the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuji Takayama |
Organization
Tokushima University Graduate School, The Institute of Biomedical Sciences, Department of Gastroenterology and Oncology
Division name
Gastroenterology and Oncology
Zip code
Address
3-18-15, Kuramoto-cho, Tokushima city
TEL
088-633-7122
takayama@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisaku Fujimoto |
Organization
Tokushima University Graduate School, The Institute of Biomedical Sciences
Division name
Department of Gastroenterology and Oncology
Zip code
Address
3-18-15, Kuramoto-cho, Tokushima city
TEL
088-633-7122
Homepage URL
dfdfdf_1981@yahoo.co.jp
Sponsor or person
Institute
Tokushima University Hospital, Department of Gastroenterology and Oncology
Institute
Department
Personal name
Funding Source
Organization
Tokushima University Hospital, Department of Gastroenterology and Oncology
Organization
Division
Category of Funding Organization
Non profit foundation
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 | 05 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 01 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 27 | 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
| 2015 | Year | 05 | Month | 18 | Day |
Last modified on
| 2015 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019366
| 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 |
