UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	hiromasa-takahashi@cmic.co.jp

Sponsor
Institute	CMIC HealthCare Institute Co., Ltd.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046150