UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061126 |
|---|---|
| Receipt number | R000069943 |
| Scientific Title | An Assessment of the Risk of Cervical Cancer and Precancerous Lesions in Women with Negative Cytology and Positive Human Papillomavirus in Cervical Cancer Screening |
| Date of disclosure of the study information | 2026/04/02 |
| Last modified on | 2026/04/01 14:06:33 |
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Basic information
Public title
An Assessment of the Risk of Cervical Cancer and Precancerous Lesions in Women with Negative Cytology and Positive Human Papillomavirus in Cervical Cancer Screening
Acronym
An Assessment of the Risk of Cervical Cancer and Precancerous Lesions in Women with Negative Cytology and Positive Human Papillomavirus in Cervical Cancer Screening
Scientific Title
An Assessment of the Risk of Cervical Cancer and Precancerous Lesions in Women with Negative Cytology and Positive Human Papillomavirus in Cervical Cancer Screening
Scientific Title:Acronym
An Assessment of the Risk of Cervical Cancer and Precancerous Lesions in Women with Negative Cytology and Positive Human Papillomavirus in Cervical Cancer Screening
Region
| Japan |
Condition
Condition
Women with a negative cytology (NILM) and positive high-risk HPV in cervical cancer screening
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the risk of cervical dysplasia in women who are cytologically negative (NILM) but positive for high-risk HPV in cervical cancer screening.
Basic objectives2
Others
Basic objectives -Others
Comparison of the absolute risk of CIN 2 or higher by HPV genotype and group in NILM/HPV(+), and the absolute risk of CIN 2 or higher in ASC-US/HPV(+)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Absolute risk of CIN 2 or higher in NILM/HPV(+)
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
| 30 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
Women aged 30 to 65 who undergo cervical cancer screening in Kagoshima City and who have agreed to participate in this study. Excluded are women who are pregnant or who have been receiving treatment for cervical cancer or precancerous lesions during the past year.
Key exclusion criteria
Other than the above
Target sample size
30000
Research contact person
Name of lead principal investigator
| 1st name | Shintaro |
| Middle name | |
| Last name | Yanazume |
Organization
Kagoshima University Hospital
Division name
Obstetrics & Gynecology
Zip code
890-8520
Address
8-35-1 Sakuragaoka, Kagoshima City
TEL
0992755423
s-yana@m3.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Yanazume |
Organization
Kagoshima University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
890-8520
Address
8-35-1 Sakuragaoka, Kagoshima City
TEL
0992755423
Homepage URL
s-yana@m3.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Hospital
Institute
Department
Personal name
Shintaro Yanazume
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Obstetrics & Gynecology, Faculty of Medicine, Kagoshima University
Address
8-35-1 Sakuragaoka, Kagoshima City
Tel
0992755423
s-yana@m3.kufm.kagoshima-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
鹿児島県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 02 | 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
| 2025 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study evaluates women aged 30 to 65 who undergo cervical cancer screening at screening facilities in Kagoshima City, including HPV testing along with cervical cancer screening, and analyzes the aforementioned evaluation items.
Management information
Registered date
| 2026 | Year | 04 | Month | 01 | Day |
Last modified on
| 2026 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069943
