UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045183 |
|---|---|
| Receipt number | R000051618 |
| Scientific Title | Validation of the effectiveness of a self-sampling high-risk human papillomavirus (hrHPV) test through the Web: a prospective study using questionnaires in hrHPV-positive women on the possibility of motivating them to receive cervical cancer screening and its usefulness as a CIN 2 or worse detection tool |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2024/08/29 14:51:21 |
* 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
Validation of the effectiveness of a self-sampling high-risk human papillomavirus (hrHPV) test through the Web: a prospective study using questionnaires in hrHPV-positive women on the possibility of motivating them to receive cervical cancer screening and its usefulness as a CIN 2 or worse detection tool
Acronym
A validation study of the effectiveness of a self-sampling high-risk human papillomavirus test through the Web for cervical cancer screening (VEST study)
Scientific Title
Validation of the effectiveness of a self-sampling high-risk human papillomavirus (hrHPV) test through the Web: a prospective study using questionnaires in hrHPV-positive women on the possibility of motivating them to receive cervical cancer screening and its usefulness as a CIN 2 or worse detection tool
Scientific Title:Acronym
A validation study of the effectiveness of a self-sampling high-risk human papillomavirus test through the Web for cervical cancer screening (VEST study)
Region
| Japan |
Condition
Condition
cervical cancer and cervical intraepithelial neoplasia
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effectiveness of a self-sampling hrHPV test through the Web as a countermeasure to women who are not able to receive cervical cancer screening and to determine whether it contributes to improving the cervical cancer screening uptake and to improving the detection rate of CIN 2 or worse and cervical cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The detection rate of cervical intraepithelial neoplasia grade 2 (CIN 2) or worse during whole periods
Key secondary outcomes
Application rate for self-sampling hrHPV test through the Web
Frequency of self-sampling hrHPV testing
Positive rate of hrHPV tests
Invalid specimens rate for testing
Questionnaire survey
Frequency of receiving cervical cancer screening
Frequency of receiving cytology
Frequency of detailed examination required
Frequency of receiving detailed examination
Detection rate of CIN 2 or worse per cytology
Frequency of adverse events
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
| Not applicable |
Gender
Female
Key inclusion criteria
(1) Women over 20 years old
(2) Policyholders and insured women who have subscribed to insurance products of TAIYO LIFE INSURANCE COMPANY
(3) Women who take the self-sampling hrHPV test service through the Web "PAPI'Qss" provided by GeneticLab from September 1, 2021 to August 31, 2024.
Key exclusion criteria
(1) Women who do not consent to participate
(2) Male
(3) Women less than 20 years old
(4) Women in pregnancy
(5) Women who are judged inappropriate for the test by a doctor
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Hideo |
| Middle name | |
| Last name | Satake |
Organization
Eurofins GeneticLab Co., Ltd.
Division name
Pathology Center
Zip code
0600009
Address
28-196, N9-W15, Chuo-ku, Sapporo, Hokkaido 060-0009, JAPAN
TEL
011-644-7333
selfhpv@gene-lab.com
Public contact
Name of contact person
| 1st name | Akari |
| Middle name | |
| Last name | Nagasaki |
Organization
Eurofins GeneticLab Co., Ltd.
Division name
Administration Department Sales Promotion Team
Zip code
0600009
Address
28-196, N9-W15, Chuo-ku, Sapporo, Hokkaido 060-0009, JAPAN
TEL
011-644-7333
Homepage URL
https://papiqss.jp/index_taiyou.php
patho@gene-lab.com
Sponsor or person
Institute
Eurofins GeneticLab Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
TAIYO LIFE AGING SOCIETY INSTITUTE Co., Ltd.
TAIYO LIFE INSURANCE COMPANY
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Eurofins GeneticLab Ethics Committee
Address
28-196, N9-W15, Chuo-ku, Sapporo, Hokkaido 060-0009, JAPAN
Tel
011-644-7333
akari_nagasaki@gene-lab.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
ユーロフィンジェネティックラボ株式会社（旧社名：株式会社ジェネティックラボ） 病理解析センター（北海道）
Eurofins GeneticLab Co., Ltd. Pathology Center (HOKKAIDO)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | 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
Terminated
Date of protocol fixation
| 2021 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Policyholders and insured women who have subscribed to insurance products of TAIYO LIFE INSURANCE CONPANY are invited to participate in this study.
Women who take the self-sampling hrHPV test service through the Web "PAPI'Qss" provided by GeneticLab from September 1, 2021 to August 31, 2024 consenting to participate in this study register in the cases.
Among the participants, cases with positive hrHPV test results are extracted, and a questionnaire survey is conducted 3 months after the test. To participants who do not respond to this survey a repeat questionnaire survey is conducted one year after taking the test.
Management information
Registered date
| 2021 | Year | 08 | Month | 18 | Day |
Last modified on
| 2024 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051618
