UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062710 |
|---|---|
| Receipt number | R000071801 |
| Scientific Title | Evaluation of Standard Specimen Preparation Method and Diagnostic Accuracy for Endometrial Cytology Using ThinPrep Liquid-Based Cytology |
| Date of disclosure of the study information | 2026/08/27 |
| Last modified on | 2026/08/27 14:02:06 |
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Basic information
Public title
Evaluation of Endometrial Cytology Using ThinPrep Liquid-Based Cytology
Acronym
Evaluation for Endometrial Cytology Using ThinPrep
Scientific Title
Evaluation of Standard Specimen Preparation Method and Diagnostic Accuracy for Endometrial Cytology Using ThinPrep Liquid-Based Cytology
Scientific Title:Acronym
Evaluation for Endometrial Cytology Using ThinPrep Liquid-Based Cytology
Region
| Japan |
Condition
Condition
Endometrial Cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
For patients requiring pathological evaluation of the endometrium (uterine corpus), this study aims to clarify the validity of the standard specimen preparation method and the diagnostic accuracy of ThinPrep endometrial cytology by comparing cytologic interpretation results with histological diagnosis results.
Basic objectives2
Others
Basic objectives -Others
Endometrial cytology is a primary initial test for detecting endometrial cancer. While the lesion detection rate of endometrial cytology in Japan is considered comparable or superior to that of histological diagnosis, the diagnostic accuracy for cases classified as "suspicious" (equivocal) is reported to be around 50%, indicating that diagnostic performance is not necessarily optimal. ThinPrep is the most widely adopted method globally and accounts for approximately 50% of the liquid-based cytology (LBC) market in Japan. Therefore, this study - which examines the cytological appearance of samples prepared using the standard ThinPrep method, establishes diagnostic criteria, and evaluates diagnostic accuracy - is expected to contribute to the further adoption and improved accuracy of endometrial cytology.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Proportion of adequate samples in endometrial cytology using the standard ThinPrep slide preparation method
2) Comparison of ThinPrep interpretation results with histological diagnosis results (sensitivity, specificity, positive predictive value, and negative predictive value of ThinPrep interpretations relative to histological diagnoses; Cytology positive: ATEC-AE, atypical endometrial hyperplasia, or malignant tumor based on TYS classification; Histology positive: atypical endometrial hyperplasia or malignant tumor)
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Women aged 18 years or older requiring pathological evaluation of the endometrium (uterine corpus) who underwent both cytology and histology - specifically, those who underwent histology either concurrently with cytology or within three months following the cytology procedure.
Key exclusion criteria
Patients who do not provide consent; patients deemed unsuitable for participation by their attending physician.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Matsumoto |
Organization
Ehime University Hospital
Division name
Obstetrics and Gynecology
Zip code
790-0295
Address
454 Shizugawa, Toon City, Ehime
TEL
089-960-5379
matsugen@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Matsumoto |
Organization
Ehime University Hospital
Division name
Obstetrics and Gynecology
Zip code
790-0295
Address
454 Shizugawa, Toon City, Ehime
TEL
089-960-5379
Homepage URL
matsugen@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Funding Source
Organization
Suzuka Steering Committee
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
Institutional Review Board for Clinical Research, Ehime University Hospital
Address
454 Shizugawa, Toon City, Ehime
Tel
089-960-5172
rinri@m.ehime-u.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 | 08 | Month | 27 | 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
| 2026 | Year | 06 | Month | 04 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 08 | Day |
Last follow-up date
| 2028 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 08 | Month | 27 | Day |
Last modified on
| 2026 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071801
