UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026757 |
|---|---|
| Receipt number | R000030718 |
| Scientific Title | Investigation of cervical HPV infection in Niigata |
| Date of disclosure of the study information | 2017/03/29 |
| Last modified on | 2020/01/11 11:43:09 |
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Basic information
Public title
Investigation of cervical HPV infection in Niigata
Acronym
Investigation of cervical HPV infection
Scientific Title
Investigation of cervical HPV infection in Niigata
Scientific Title:Acronym
Investigation of cervical HPV infection
Region
| Japan |
Condition
Condition
cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigation of age-specific cervical HPV infection rate in Niigata
Basic objectives2
Others
Basic objectives -Others
Survey of infection rate
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Infection rate of high-risk HPV
Key secondary outcomes
1.Rate of abnormal cytology
2.Sexual activity by questionnaire (number of sexual partners and sexual debut age)
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
| 41 | years-old | >= |
Gender
Female
Key inclusion criteria
Medical examinee of cervical cancer screening by public health program in Niigata city
Key exclusion criteria
None
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Enomoto |
Organization
Niigata University Graduate School of Medical and Dental Science
Division name
Department of Obstetrics and Gynecology
Zip code
951-8510
Address
Chuo-ku
TEL
0252272320
masa@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Sekine |
Organization
Niigata University
Division name
Department of Obstetrics and Gynecology
Zip code
951-8510
Address
Chuo-ku
TEL
0252272320
Homepage URL
masa@med.niigata-u.ac.jp
Sponsor or person
Institute
Department of Obstetrics and Gynecology, Niigata University Graduate School of Medical and Dental Science
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University Graduate School of Medical and Dental Science
Address
Asahimachi-Dori 1-757, Niigata, Japan
Tel
025-227-2625
sanonao@adm.niigata-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
新潟大学大学院医歯学総合研究科（新潟県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 29 | 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
3968
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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Rate of HPV infection and abnormal cytology in 20-30, 34-35 and 40-41 years old females in Niigata will be invesigated, and furthermore, relationship between HPV infection, cytological abnormality and sexual activity will be examined.
Management information
Registered date
| 2017 | Year | 03 | Month | 29 | Day |
Last modified on
| 2020 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030718
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
