UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009763 |
|---|---|
| Receipt number | R000011404 |
| Scientific Title | Usefulness of a novel auto-fluorescence imaging system with computer-assisted color analysis for colorectal lesions |
| Date of disclosure of the study information | 2013/01/15 |
| Last modified on | 2013/05/08 17:26:20 |
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Basic information
Public title
Usefulness of a novel auto-fluorescence imaging system with computer-assisted color analysis for colorectal lesions
Acronym
Colon a novelAFI Study
Scientific Title
Usefulness of a novel auto-fluorescence imaging system with computer-assisted color analysis for colorectal lesions
Scientific Title:Acronym
Colon a novelAFI Study
Region
| Japan |
Condition
Condition
Neoplastic and non-neoplastic lesions of the colon
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to prospectively evaluate the efficacy of computer-assisted color analysis of colorectal lesions using the novel AFI system in distinguishing non-neoplastic lesions from neoplastic lesions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ability of differrential diagnosis(neoplastic,non-neoplastic)by using a novel AFI system.
Key secondary outcomes
Diagnosing the depth of invasion of colorectal neoplasia by using a novel AFI system.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-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
A novel AFI system
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients over 20 under 90 years old who undergo total colonoscopy.
Key exclusion criteria
IBD
FAP
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroko Inomata |
Organization
The Jikei University Hospital
Division name
Depertment of Endoscopy
Zip code
Address
3-19-18 nishi-shinbashi Minatoku Tokyo Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The Jikei University Hospital
Division name
Depertment of Endoscopy
Zip code
Address
TEL
Homepage URL
hirokomoko@hotmail.co.jp
Sponsor or person
Institute
Depertment of Endoscopy at The Jikei University Hospital
Institute
Department
Personal name
Funding Source
Organization
Depertment of Endoscopy at The Jikei University 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
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
| 2013 | Year | 01 | Month | 15 | 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
| 2012 | Year | 12 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 12 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 12 | Day |
Date trial data considered complete
| 2013 | Year | 04 | Month | 12 | Day |
Date analysis concluded
| 2013 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 12 | Day |
Last modified on
| 2013 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011404
| 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 |
