UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059876 |
|---|---|
| Receipt number | R000068452 |
| Scientific Title | Optimization of Atypical Cell Assessment in the Uterine Cervix |
| Date of disclosure of the study information | 2026/11/01 |
| Last modified on | 2025/11/22 18:14:51 |
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Basic information
Public title
Optimization of Atypical Cell Assessment in the Uterine Cervix
Acronym
Optimization of Atypical Cell Assessment in the Uterine Cervix
Scientific Title
Optimization of Atypical Cell Assessment in the Uterine Cervix
Scientific Title:Acronym
Optimization of Atypical Cell Assessment in the Uterine Cervix
Region
| Japan |
Condition
Condition
medical technologist or cytotechnologist
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will have cytotechnologists make cytological diagnosis judgments before and after using learning tools such as AI-assisted diagnosis, and compare the accuracy rate before and after learning to examine the possibility that AI-assisted diagnosis will lead to improvements in the diagnostic ability and accuracy of cytological diagnosis among cytotechnologists.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correct answer rate of cytotechnologists before and after using the learning tool.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Use of AI-assisted diagnosis.
Interventions/Control_2
Use of educational photos.
Interventions/Control_3
Do not use learning tools.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Our clinical laboratory technicians or cytotechnologists.
Cytotechnologist affiliated with Saitama society of cytotechnologists.
Key exclusion criteria
Not applicable.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Miho |
| Middle name | |
| Last name | Kobuna |
Organization
Saitama Medical University International Medical Center.
Division name
Department of pathology
Zip code
350-1298
Address
1397-1 Yamane, Hidaka, Saitama, JAPAN
TEL
042-984-0609
mk09941@5931.saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Kobuna |
Organization
Saitama medical University International Medical Center
Division name
Department of pathology
Zip code
350-1298
Address
1397-1 Yamane, Hidaka, Saitama, JAPAN
TEL
042-984-0609
Homepage URL
mk09941@5931.saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University International Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University International Medical Center IRB
Address
1397-1 Yamane, Hidaka, Saitama, JAPAN
Tel
042-984-4523
chikens@saitama-med.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
| 2026 | Year | 11 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 25 | Day |
Last modified on
| 2025 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068452
