UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019355 |
|---|---|
| Receipt number | R000022364 |
| Scientific Title | Efficacy of Autofluorescence imaging on flat adenoma detection; a randomized controlled trial |
| Date of disclosure of the study information | 2015/10/20 |
| Last modified on | 2018/10/17 12:15:40 |
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Basic information
Public title
Efficacy of Autofluorescence imaging on flat adenoma detection; a randomized controlled trial
Acronym
Efficacy of AFI on flat adenoma detection (A-FLAT trial)
Scientific Title
Efficacy of Autofluorescence imaging on flat adenoma detection; a randomized controlled trial
Scientific Title:Acronym
Efficacy of AFI on flat adenoma detection (A-FLAT trial)
Region
| Japan |
Condition
Condition
Colonic neoplasm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of auto fluorescence imaging (AFI) for detection of flat colonic neoplasm compared to white light imaging (WLI)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
detected number of flat colonic neoplasms per patient
Key secondary outcomes
detected number of colonic polyp per patient
Adenoma detection rate
Polyp detection rate
Advanced neoplasia detection rate
Detected number of advanced neoplasia per patient
Detected number of sessile serrated adenoma/polyp (SSA/P) per patient
Detected number of polyps according to morphology (flat/protruded)
Detected number of adenomas according to the size.
Procedure time (intubation and withdrawal time)
Adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
White light imaging
Interventions/Control_2
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
1. Patients undergoing colonoscopy for investigation of FIT, surveillance after polypectomy, or investigation for minor symptoms.
2. Patients obtained written informed consent.
Key exclusion criteria
1. Suspicious patient for advanced cancer.
2. Patient with IBD, polyposis, colon cancer, or colorectal polyps.
3. Patient with previous colorectomy or major abdominal surgery.
4. Patient with non-correctable coagulopathy.
5. Patient with severe organ failure.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahisa Matsuda |
Organization
National Cancer Center Hospital
Division name
Research Center for Cancer Prevention and Screening
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
tamatsud@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoji Takeuchi |
Organization
Osaka International Cancer Institute
Division name
Gastrointestinal Oncology
Zip code
Address
3-1-69, Otemae, Chuo-ku, Osaka, Japan
TEL
06-6945-1181
Homepage URL
takeuti-yo@mc.pref.osaka.jp
Sponsor or person
Institute
Endoscopic Forum Japan
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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 | 10 | Month | 20 | 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
Main results already published
Date of protocol fixation
| 2015 | Year | 10 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 12 | Day |
Date of closure to data entry
| 2017 | Year | 09 | Month | 13 | Day |
Date trial data considered complete
| 2017 | Year | 09 | Month | 13 | Day |
Date analysis concluded
| 2017 | Year | 10 | Month | 12 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 15 | Day |
Last modified on
| 2018 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022364
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2017/09/22 | A-Flat：クリーニング後(UMIN登録用).xlsx |
