UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013450 |
|---|---|
| Receipt number | R000015686 |
| Scientific Title | A study of acceptability and efficacy of self-sampling methods for human papillomavirus (HPV) detection in Japanese women with abnormal cervical cytology. |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2014/03/16 18:30:28 |
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Basic information
Public title
A study of acceptability and efficacy of self-sampling methods for human papillomavirus (HPV) detection in Japanese women with abnormal cervical cytology.
Acronym
A study of acceptability and efficacy of self-sampling methods for human papillomavirus (HPV) detection in Japanese women with abnormal cervical cytology.
Scientific Title
A study of acceptability and efficacy of self-sampling methods for human papillomavirus (HPV) detection in Japanese women with abnormal cervical cytology.
Scientific Title:Acronym
A study of acceptability and efficacy of self-sampling methods for human papillomavirus (HPV) detection in Japanese women with abnormal cervical cytology.
Region
| Japan |
Condition
Condition
Cervical intraepithelial neoplasia
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the acceptability of the self-sampling methods for HPV detection.
To clarify the association of self-sampling HPV positive group and CIN compared to self-sampling HPV negative group.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Acceptabiity of self sampling method
Detection of CIN
Key secondary outcomes
Difference of HPV positive rate between docter sampling test and self sampling test
Safety
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
| Device,equipment | Maneuver |
Interventions/Control_1
Self sampling HPV test: Take self sampling kit to home, collect sample at home, and send it to our hospital.
Docter sampling HPV test
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 over 20 years old, who has or had abnormal cervical smear. Abnormal cervical smear include all smears except diagnosed negative for intraepithelial lesion or malignancy (NILM) by the Bethesda system.
Key exclusion criteria
Apparent cervical invasive cancer
Pregnancy
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Aiko Yashiro |
Organization
Yokohama City University Hospital
Division name
Department of obstetrics and gynecology
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama city, Kanagawa prefecture, Japan
TEL
045-787-2800
m13023@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Aiko Yashiro |
Organization
Yokohama City University Hospital
Division name
Department of obstetrics and gynecology
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama city, Kanagawa prefecture, Japan
TEL
045-787-2800
Homepage URL
m13023@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 04 | 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
| 2014 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 18 | Day |
Last modified on
| 2014 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015686
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
