UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040603 |
|---|---|
| Receipt number | 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 | 2022/06/03 10:43:04 |
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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
| Obstetrics 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
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
akimatsu@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Japan
Institute
Department
Personal name
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
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
| Delay expected |
Results Delay Reason
Due to difficulty in recruiting participants due to the COVID-19 outbreak
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
| 2022 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046340
