UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042818 |
|---|---|
| Receipt number | R000048861 |
| Scientific Title | Usability of image-enhanced endoscope system (Lezario: FUJIFILM Corporation) in familial adenomatous polyposis |
| Date of disclosure of the study information | 2020/12/22 |
| Last modified on | 2021/10/29 16:01:34 |
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Basic information
Public title
Usability of image-enhanced endoscope system (Lezario: FUJIFILM Corporation) in familial adenomatous polyposis
Acronym
Usability of image-enhanced endoscope system (Lezario: FUJIFILM Corporation) in familial adenomatous polyposis
Scientific Title
Usability of image-enhanced endoscope system (Lezario: FUJIFILM Corporation) in familial adenomatous polyposis
Scientific Title:Acronym
Usability of image-enhanced endoscope system (Lezario: FUJIFILM Corporation) in familial adenomatous polyposis
Region
| Japan |
Condition
Condition
familial adenomatous polyposis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to collect on the observation ability of neoplastic lesion in fundic gland polyp by the image-enhanced endoscope system (Lezario: FUJIFILM Co) in familial adenomatous polyposis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Characteristics of endoscopic findings compared with conventional white light of linked color imaging and blue laser imaging of neoplastic lesions in fundic gland polyp in familial adenomatous polyposis
Key secondary outcomes
1. Usability of upper gastrointestinal endoscopy in familial adenomatous polyposis (FAP)
2. Usability of colonoscopy in FAP
3. Compare the detection rate of polyps conventional white light of linked color imaging (LCI) and blue laser imaging (BLI) of upper gastrointestinal endoscopy in FAP
4. Compare the detection rate of colon polyps conventional white light of LCI and BLI in FAP
5. Compare the qualititative diagnosis of polyps conventional white light of LCI and BLI of upper gastrointestinal endoscopy in FAP
6. Compare the detection rate of colon polyps conventional white light of LCI and BLI in FAP
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. FAP patients who visited Ishikawa Gastrointestinal clinic between approval date and December 31, 2023
2. aged 16 years or older at the time of endoscopy
3. regardless of gender
4. Outpatients only
Key exclusion criteria
1. Evaluated not to be appropriate for inclusion by attending physician
2. When the subject refuses to participate in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Ishikawa |
Organization
Ishikawa gastrointestinal clinic
Division name
Director
Zip code
541-0042
Address
3-2-17, imabashi, chuo-ku, Osaka
TEL
06-6202-6566
cancer@gol.com
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Ishikawa |
Organization
Ishikawa gastrointestinal clinic
Division name
Director
Zip code
541-0042
Address
3-2-17, Imabashi, chuo-ku, Osaka
TEL
0662026566
Homepage URL
cancer@gol.com
Sponsor or person
Institute
Ishikawa gastrointestinal clinic
Director
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
Kyoto Prefectural University of Medicine
Address
Kawaramachi-hiroko-ji, Kamigyo-ku, Kyoto 602-8566
Tel
075-251-5111
rinri@koto.kpu-m.ac.jp
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
| 2020 | Year | 12 | Month | 22 | 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
| 2020 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation contents: medical record, endoscope photograph, endoscope moving image
Management information
Registered date
| 2020 | Year | 12 | Month | 22 | Day |
Last modified on
| 2021 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048861
| Research Plan | |
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| 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 |
