UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040974 |
|---|---|
| Receipt number | R000046788 |
| Scientific Title | Advanced endoscopic imaging to diagnose advanced histology of small colorectal polyps: a multicenter prospective observational trial |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2023/07/04 15:42:16 |
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Basic information
Public title
Advanced endoscopic imaging to diagnose advanced histology of small colorectal polyps: a multicenter prospective observational trial
Acronym
ADVENTURE trial
Scientific Title
Advanced endoscopic imaging to diagnose advanced histology of small colorectal polyps: a multicenter prospective observational trial
Scientific Title:Acronym
ADVENTURE trial
Region
| Japan |
Condition
Condition
Colorectal polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove efficacy of image enhanced endoscopy for predicting advanced histology of small colorectal polyps
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Phase II
Assessment
Primary outcomes
Negative predictive value of diagnosis of advanced histology using WLI+NBI+IC
Key secondary outcomes
(1)Sensitivity, Specificity and positive predictive value of diagnosis of advanced histology using WLI+NBI+IC
(2)Diagnostic parameter of other combinations of diagnosis of advanced histology
(3)Rate of non-cold snare polypectomy for advanced histology
(4)Complications(perforation, bleeding, GI symptoms)
(5)Rate of surgical margin negative
(6)Rate of including MM and SM
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Patients for elective colonoscopy
(2)Patients who can be obtained informed consent
Key exclusion criteria
(1)Patients with advanced colorectal cancers
(2)Patients with hemorrhagic disorders
(3)FAP, Polyposis, Lynch syndrome
(4)Patients with hemorrhagic tendency
(5)Patients with anti-thrombotic agents
(6)Pregnancy
(7)Disqualified patients with other reasons
Target sample size
1100
Research contact person
Name of lead principal investigator
| 1st name | Kinichi |
| Middle name | |
| Last name | Hotta |
Organization
Shizuoka Cancer Center
Division name
Division of Endoscopy
Zip code
4118777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL
055-989-5222
k.hotta@scchr.jp
Public contact
Name of contact person
| 1st name | Kinichi |
| Middle name | |
| Last name | Hotta |
Organization
Shizuoka Cancer Center
Division name
Division of Endoscopy
Zip code
4118777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL
055-989-5222
Homepage URL
k.hotta@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Division of Endoscopy
Institute
Department
Personal name
Funding Source
Organization
Shizuoka Cancer Center
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
IRB of Shizuoka Cancer Center
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
Tel
055-989-5222
n/a
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
静岡県立静岡がんセンター(静岡県）
大阪国際がんセンター（大阪府）
静岡県立総合病院（静岡県）
京都第二赤十字病院（京都府）
神戸市立医療センター中央市民病院（兵庫県）
豊川市民病院（愛知県）
伊勢赤十字病院（三重県）
京都桂病院（京都府）
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
| 2020 | Year | 07 | 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
| 2020 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 01 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
No information
Management information
Registered date
| 2020 | Year | 07 | Month | 01 | Day |
Last modified on
| 2023 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046788
