UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034949 |
|---|---|
| Receipt number | R000039848 |
| Scientific Title | A study on the usefulness of self-harvesting of HPV test and Chlamydia test |
| Date of disclosure of the study information | 2018/11/25 |
| Last modified on | 2020/01/07 10:50:54 |
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Basic information
Public title
A study on the usefulness of self-harvesting of HPV test and Chlamydia test
Acronym
A study on the usefulness of self-harvesting of HPV test and Chlamydia test
Scientific Title
A study on the usefulness of self-harvesting of HPV test and Chlamydia test
Scientific Title:Acronym
A study on the usefulness of self-harvesting of HPV test and Chlamydia test
Region
| Japan |
Condition
Condition
Cervical cancer
Chlamydia infection
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We conduct HPV (human papilloma virus) examination by autologous cell harvesting to non-consulted persons who do not have cervical cancer screening examinations, and examine the usefulness of HPV self-harvesting compared with the examination by doctors. The purpose of this study is to find a method leading to the early detection of cervical cancer in the absence of improved gynecological examination rate by verifying the usefulness of self-screening for those who have not undergone cervicl cancer screening examination.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concordance rate of HPV and Chlamydia between self-harvesting and physician harvesting.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy women between 20 and 65 years old.
People with sexual experiences.
Those who can obtain consent in participating in this research in writing.
Key exclusion criteria
When there is a possibility of pregnancy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Mihyon |
| Middle name | |
| Last name | Song |
Organization
Marunouchi no Mori Ladies Clinic
Division name
Gynecology
Zip code
1006509
Address
Shin Marunouchi Building, 9th Floor, 1-5-1 Marunouchi, Chiyoda-ku, Tokyo
TEL
03-6206-3900
gyne@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Mihyon |
| Middle name | |
| Last name | Song |
Organization
Marunouchi no Mori Ladies Clinic
Division name
Gynecology
Zip code
1006509
Address
Shin Marunouchi Building, 9th Floor, 1-5-1 Marunouchi, Chiyoda-ku, Tokyo
TEL
03-6206-3900
Homepage URL
gyne@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Marunouchi no Mori Ladies Clinic
Institute
Department
Personal name
Funding Source
Organization
Marunouchi no Mori Ladies Clinic
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical University
Address
Matsushima 577 Kurashiki-shi, Okayama prefecture
Tel
086-462-1111
gyne@med.kawasaki-m.ac.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
| 2018 | Year | 11 | Month | 25 | 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
Completed
Date of protocol fixation
| 2018 | Year | 11 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
non
Management information
Registered date
| 2018 | Year | 11 | Month | 20 | Day |
Last modified on
| 2020 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039848
