UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040440
Receipt No. 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 2020/05/18

* 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 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 Pseudo-randomization

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 Medical Research 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
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
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 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 05 Month 18 Day
Last modified on
2020 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046150

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.