UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040440 |
|---|---|
| Receipt number | R000046150 |
| Scientific Title | Clinical study confirming the usefulness of cervical cell self-collection in Human Papilloma Virus test |
| Date of disclosure of the study information | 2020/05/18 |
| Last modified on | 2021/05/31 12:07:50 |
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Basic information
Public title
Clinical study confirming the usefulness of cervical cell self-collection in Human Papilloma Virus test
Acronym
Clinical study confirming the usefulness of cervical cell self-collection in Human Papilloma Virus test
Scientific Title
Clinical study confirming the usefulness of cervical cell self-collection in Human Papilloma Virus test
Scientific Title:Acronym
Clinical study confirming the usefulness of cervical cell self-collection in Human Papilloma Virus test
Region
| Japan |
Condition
Condition
HPV infection
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the HPV test results of self-collected cervical cells with the HPV test results of doctor-collected cervical cells to confirming the usefulness of self-collected HPV test.
Basic objectives2
Others
Basic objectives -Others
Overall conformity ratio in HPV measurement
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall conformity ratio in HPV measurement
Key secondary outcomes
Positive conformity ratio in HPV measurement
Negative conformity ratio in HPV measurement
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Subjects will self-collect cervical cells using HSP.
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
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
1) Women over 20 and under 50
2) Those who can cooperate with cervical cell collection
3) Those who can obtain written consent from the subject
Key exclusion criteria
1) Those who have judged that it is inappropriate for the investigators to collect during menstruation or less than one week after the menstruation
2) Pregnant women
3) Those who have undergone a total hysterectomy
4) In addition, those who the investigators in charge of research judges to be inappropriate
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Nobuyoshi |
| Middle name | |
| Last name | Ozawa |
Organization
Ozawa Josei Sogo Clinic
Division name
Director
Zip code
984-0073
Address
192 Aramachi, Wakabayashi-ku, Sendai City, Miyagi 984-0073, Japan
TEL
022-222-9716
nobuyosi@mva.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | Hiromasa |
| Middle name | |
| Last name | Takahashi |
Organization
CMIC Co., Ltd.
Division name
Clinical Operation 3rd Div.
Zip code
105-0023
Address
Hamamatsucho Building 1-1-1 Shibaura, Minato-ku, Tokyo 105-0023, JAPAN
TEL
03-6779-8000
Homepage URL
hiromasa-takahashi@cmic.co.jp
Sponsor or person
Institute
CMIC HealthCare Institute Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
CMIC HealthCare Institute Co., Ltd.
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
Kitamachi clinic
Address
1-1-3 Kitamachi, Musashino-city, Tokyo
Tel
070-5011-8550
shingo-namiki@cmicgroup.com
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
| 2020 | Year | 05 | Month | 18 | 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
165
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
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 28 | Day |
Date trial data considered complete
| 2021 | Year | 02 | Month | 10 | Day |
Date analysis concluded
| 2021 | Year | 04 | Month | 13 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 18 | Day |
Last modified on
| 2021 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046150
