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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

Not Applicable
Recruiting
Conditions
cervical cancer and cervical intraepithelial neoplasia
Registration Number
JPRN-UMIN000045183
Lead Sponsor
Eurofins GeneticLab Co., Ltd.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Female
Target Recruitment
5000
Inclusion Criteria

Not provided

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

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The detection rate of cervical intraepithelial neoplasia grade 2 (CIN 2) or worse during whole periods
Secondary Outcome Measures
NameTimeMethod
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
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