JRCT ID: jRCTs051190039
Registered date:21/08/2019
HAKUOH Study
Basic Information
Recruitment status | Not Recruiting |
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Health condition(s) or Problem(s) studied | Uterine cervical cancer |
Date of first enrollment | 21/08/2019 |
Target sample size | 2100 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | arm A:vaccine group 3 times(0 month, 2 month, 6 month) arm B:non-vaccine group |
Outcome(s)
Primary Outcome | Persistent inflectional rate |
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Secondary Outcome | Vaccinationrate by age group,Persistent inflectional rate by age group |
Key inclusion & exclusion criteria
Age minimum | >= 27age old |
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Age maximum | <= 45age old |
Gender | Female |
Include criteria | Inclusion criteria: >Women with normal cytology results confirmed in cervical cancer screening programs from May 2019 to March 2020 >27-45 years-old >Intact uterus >Willing to undergo the HPV-DNA test (cobas4800) within 12 months |
Exclude criteria | Exclusion criteria >Pregnant women >Undergo treatment or the follow-up evaluation for CIN within the previous 12 months >Previously administered HPV vaccine |
Related Information
Primary Sponsor | Yoshida Yoshio |
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Secondary Sponsor | Shinagawa Akiko |
Source(s) of Monetary Support | Merck Sharp & Dohme Corp. |
Secondary ID(s) |
Contact
Public contact | |
Name | Akiko Shinagawa |
Address | 23-3Matsuoka Shimoaiduki,Eiheiji-cho,Yoshida-gun,Fukui Fukui Japan 910-1193 |
Telephone | +81-776-61-8392 |
hakuoh@ml.u-fukui.ac.jp | |
Affiliation | University of Fukui Hospital |
Scientific contact | |
Name | Yoshio Yoshida |
Address | 23-3Matsuoka Shimoaiduki,Eiheiji-cho,Yoshida-gun,Fukui Fukui Japan 910-1193 |
Telephone | +81-776-61-8392 |
yyoshida@u-fukui.ac.jp | |
Affiliation | University of Fukui Hospital |