UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056523 |
|---|---|
| Receipt number | R000064436 |
| Scientific Title | Observational study to evaluate the risk of cervical cancer/precancerous lesions in individuals with negative cervical cytology but positive human papillomavirus (HPV) test results in cervical cancer screening. |
| Date of disclosure of the study information | 2024/12/20 |
| Last modified on | 2024/12/12 16:08:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Observational study to evaluate the risk of cervical cancer/precancerous lesions in individuals with negative cervical cytology but positive human papillomavirus (HPV) test results in cervical cancer screening.
Acronym
Observational study of negative cervical cytology and HPV positive.
Scientific Title
Observational study to evaluate the risk of cervical cancer/precancerous lesions in individuals with negative cervical cytology but positive human papillomavirus (HPV) test results in cervical cancer screening.
Scientific Title:Acronym
NILM and HPV positive observational study
Region
| Japan |
Condition
Condition
Cervical cancer
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the risk of cervical dysplasia in NILM and HPV-positive subjects on cervical cancer screening.
Basic objectives2
Others
Basic objectives -Others
Risk analysis
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Absolute risk of >= CIN2 among 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
1. Women aged 30 to 65 years who are undergoing cervical cancer screening at facilities in Kagoshima City.
2. Individuals who understand the purpose of this study, have agreed to participate, and have provided written informed consent.
Key exclusion criteria
1. Individuals who are pregnant.
2. Individuals currently receiving treatment for cervical cancer or precancerous lesions within the past year.
Target sample size
30000
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Kobayashi |
Organization
KAGOSHIMA UNIVERSITY Graduate School of Medical and Dental Sciences
Division name
Reproductive Pathophysiology and Obstet-Gynecology
Zip code
890-8544
Address
8-35-1, Sakuragaoka Kagoshima-city, Kagoshima Pref.
TEL
099-275-5423
hirokoba@m2.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Mika |
| Middle name | |
| Last name | Mizuno |
Organization
Kagoshima University Hospital
Division name
Department of Obstetrics & Gynecology
Zip code
890-0075
Address
8-35-1, Sakuragaoka Kagoshima-city, Kagoshima Pref.
TEL
099-275-5423
Homepage URL
https://www.hosp.kagoshima-u.ac.jp/department/015-2/
mizunomizuno@kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
Nippon Becton Dickinson Company, Ltd.
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
Ethics Committee on Epidemiological Studies, Kagoshima University
Address
8-35-1, Sakuragaoka Kagoshima-city, Kagoshima Pref.
Tel
099-275-6624
crmc@m2.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
Institutions
Institutions
鹿児島大学病院（鹿児島県）/Kagoshima University Hospital
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 20 | 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
| 2024 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cervical cancer screening
Management information
Registered date
| 2024 | Year | 12 | Month | 20 | Day |
Last modified on
| 2024 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064436
