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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040603
Receipt No. R000046340
Scientific Title A study on the behavioral change effect of self-collected HPV test for those who have not been screened for cervical cancer: A social implementation study on occupational cancer screening
Date of disclosure of the study information 2020/08/01
Last modified on 2020/06/01

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Basic information
Public title A study on the behavioral change effect of self-collected HPV test for those who have not been screened for cervical cancer: A social implementation study on occupational cancer screening
Acronym A social implementation study of self-collection HPV test for occupational cancer screening
Scientific Title A study on the behavioral change effect of self-collected HPV test for those who have not been screened for cervical cancer: A social implementation study on occupational cancer screening
Scientific Title:Acronym A social implementation study of self-collection HPV test for occupational cancer screening
Region
Japan

Condition
Condition Cervical cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to determine whether women who had not received cervical cancer screening in the last 2 years would be more likely to receive it by knowing their HPV infection status using a self-collected HPV test.
Basic objectives2 Others
Basic objectives -Others This is a social implementation study that investigates not only the usefulness of the self-collection method, but also the application for testing, submission of specimens, viewing of the results, and the subsequent receipt of medical examinations from the point of receipt of the self-collection kit.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cervical cancer screening uptake rate after self-collected HPV testing in untreated patients
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Test the mailed self-collected HPV test at home and view the results
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

Not applicable
Gender Female
Key inclusion criteria Women who have not been screened for cervical cancer in the past two years
Key exclusion criteria Women with a history of cervical cancer
Target sample size 380

Research contact person
Name of lead principal investigator
1st name Tomio
Middle name
Last name Nakayama
Organization National Cancer Center Japan
Division name Center for Public Health Sciences
Zip code 104-0045
Address 5-1-1 Tsukiji, Chuo-ku Tokyo, 104-0045 Japan
TEL 03-3542-2511
Email tomnakay@ncc.go.jp

Public contact
Name of contact person
1st name Akiko
Middle name
Last name Matsumoto
Organization National Cancer Center Japan
Division name Center for Public Health Sciences
Zip code 104-0045
Address 5-1-1 Tsukiji, Chuo-ku Tokyo, 104-0045 Japan
TEL 03-3542-2511
Homepage URL
Email akimatsu@ncc.go.jp

Sponsor
Institute National Cancer Center Japan
Institute
Department

Funding Source
Organization Hatch Healthcare K.K.
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 National Cancer Center Japan
Address 5-1-1 Tsukiji, Chuo-ku Tokyo, 104-0045 Japan
Tel 03-3542-2511
Email irst@ncc.go.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

Other administrative information
Date of disclosure of the study information
2020 Year 08 Month 01 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 Preinitiation
Date of protocol fixation
2020 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 08 Month 01 Day
Last follow-up date
2021 Year 03 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 06 Month 01 Day
Last modified on
2020 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046340

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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