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The Prospective Cohort Study to Evaluate the Preventive Efficacy of HPV Vaccine in Japanese Women Aged 27-45 Years

2,800 participantsStarted 2019-08-01

Plain-language summary

A nonrandomized, non-double blinded prospective cohort study to evaluate the preventive efficacy of quadrivalent HPV6/11/16/18 vaccine for the persistent infection of HPV16 genotype or HPV18 genotype in Japanese women aged 27-45 years.

Who can participate

Age range

27 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 Exclusion Criteria: * Pregnant women * Undergo treatment or the follow-up evaluation for CIN within the previous 12 months * Previously administered HPV vaccine

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The rate of the persistent infection

Timeframe: 48months

Trial details

NCT IDNCT04022148

SponsorUniversity of Fukui

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-12-31

Contact for this trial

Tetsuji Kurokawa, AP

+81-776-61-8392 kurotetu@u-fukui.ac.jp

View on ClinicalTrials.gov More Cancer of Cervix trials