UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054789 |
|---|---|
| Receipt number | R000062613 |
| Scientific Title | Prospective observational study of factors affecting adenoma detection rate in colonoscopy |
| Date of disclosure of the study information | 2024/06/26 |
| Last modified on | 2024/06/26 20:01:33 |
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Basic information
Public title
Prospective observational study of factors affecting adenoma detection rate in colonoscopy
Acronym
Prospective observational study of factors affecting adenoma detection rate in colonoscopy
Scientific Title
Prospective observational study of factors affecting adenoma detection rate in colonoscopy
Scientific Title:Acronym
Prospective observational study of factors affecting adenoma detection rate in colonoscopy
Region
| Japan |
Condition
Condition
Hyperplastic polyp, Sessile serrated lesion, Colorectal neoplasm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify factors affecting adenoma detecting rate (ADR) in colonoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Risk factors contributing to ADR
Key secondary outcomes
Patient background (age, gender, medical history, comorbidities, medication history, family history, etc.), examination time, presence of lesions, lesion characteristics (location, gross type, size), final pathology diagnosis, polyp detection rate, scope, whether CAD EYE (AI-based diagnostic aid) used
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
Patients scheduled to undergo screening colonoscopy
Key exclusion criteria
1. patients under 20 years of age at the time consent is obtained
2. Cases deemed unsuitable for enrolment by the investigator or sub-investigator
Target sample size
3500
Research contact person
Name of lead principal investigator
| 1st name | Motohiko |
| Middle name | |
| Last name | Kato |
Organization
Keio University School of Medicine
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
motohikokato@keio.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Minezaki |
Organization
Keio University School of Medicine
Division name
Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
d-mine@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
FUJIFILM Holdings Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
eio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2024 | Year | 06 | Month | 26 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The following information is to be carried out and collected for observations and tests.
1) Patient background
Age, gender, preferences (extent of smoking and drinking habits), medical history, comorbidities, medication history, family history, blood test findings, imaging findings (X-ray, CT, MRI, ultrasound, digestive tract examination)
2) Lower gastrointestinal endoscopy
Examination time, presence or absence of lesions, characteristics of lesions (location, gross type, size), type of endoscope used, use of CAD EYE or not
3) Pathological findings
Final pathological diagnosis
Management information
Registered date
| 2024 | Year | 06 | Month | 26 | Day |
Last modified on
| 2024 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062613
