UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003423 |
|---|---|
| Receipt number | R000004136 |
| Scientific Title | Detection of Colorectal Neoplasms by Autofluorescence Imaging: A Multicenter Randomized Controlled Trial |
| Date of disclosure of the study information | 2010/04/01 |
| Last modified on | 2016/06/21 21:21:07 |
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Basic information
Public title
Detection of Colorectal Neoplasms by Autofluorescence Imaging: A Multicenter Randomized Controlled Trial
Acronym
Colon AFI STUDY
Scientific Title
Detection of Colorectal Neoplasms by Autofluorescence Imaging: A Multicenter Randomized Controlled Trial
Scientific Title:Acronym
Colon AFI STUDY
Region
| Japan |
Condition
Condition
Colorectal Neoplasms (Adenoma, Cancer)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this multicenter randomized controlled trial is to evaluate whether a newly developed autofluorescence imaging (AFI) system can detect more colorectal neoplasms than conventional white light (WL) endoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Detection rates of colorectal neoplasms in the right-sided colon by AFI and WL.
Key secondary outcomes
1. Ability of differential diagnosis (neoplastic/non-neoplastic) by AFI and WL.
2. Detection rates of colorectal neoplasms based on the examiner's experience.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Autofluorescence Imaging (AFI)-White Light (WL)
Interventions/Control_2
White Light (WL)-Autofluorescence Imaging (AFI)
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients over 20 under 80 years old who undergo total colonoscopy.
Key exclusion criteria
IBD
FAP
HNPCC
A history of the colorectal surgery
Target sample size
540
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahisa Matsuda |
Organization
National Cancer Center Hospital
Division name
Endoscopy Division
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahisa Matsuda |
Organization
National Cancer Center Hospital
Division name
Endoscopy Division
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
tamatsud@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Health and labour sciences research grants
Organization
Division
Category of Funding Organization
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
佐久総合病院（長野県），栃木県立がんセンター（栃木県），静岡県立静岡がんセンター（静岡県），国立がん研究センター東病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 01 | 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
| 2009 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2012 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 01 | Day |
Last modified on
| 2016 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004136
| 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 |
