Cancer of CervixNCT04022148
The Prospective Cohort Study to Evaluate the Preventive Efficacy of HPV Vaccine in Japanese Women Aged 27-45 Years
An observational study of Cancer of Cervix and Vaccinia, run by University of Fukui.
Trial 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. Read more about this study
- Who is it for?
- Ages 27 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer of Cervix, Vaccinia
- What is being tested?
- Gardasil
- Type of treatment
- Vaccines
- How many people
- 2,800 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2019to 31 Dec 2020
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 27 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Japanese adult women (aged 27-45 years) undergo the cervical cancer screening.
Who may be able to join
- 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
Who cannot join
- Pregnant women
- Undergo treatment or the follow-up evaluation for CIN within the previous 12 months
- Previously administered HPV vaccine
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
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.
Read the detailed description
A series of evidence for HPV vaccines has demonstrated the efficacy in young women (Aged less than 26) across the globe. In contrast, limited evidence are available for the efficacy of the quadrivalent HPV6/11/16/18 vaccine in adult women (Aged 27+). Most importantly, evidence for Japanese adult women is not available to date. Nevertheless, , we hypothesize that the quadrivalent HPV6/11/16/18 vaccine demonstrate the efficacy also in Japanese adult women. The outcome from this trial will be the first local evidence, which brings a considerable impact in OB/GY academia where local evidence is weighed heavily compared with global evidence - serves as a strong basis to support catch up program of HPV vaccines for young adults. As a consequence, we believe this study will develop a local supportive evidence for prevention of HPV infection by an HPV vaccine in young adults, which results in substantial public health improvement through prevention of HPV infection in Japan where active recommendation is halted long time.
- Conditions
- Cancer of Cervix, Vaccinia
- Being tested
- Gardasil
- Keywords
- uterine cervical cancer, HPV vaccine, cancer screening
- Medical subject headings
- Uterine Cervical Neoplasms, Vaccinia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GardasilBiological
Experimental arm: Vaccine group VS Control arm: Non-Vaccine group
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of the persistent infection
Persistent infection is the cases that the cells from women with HPV16/18 genotype overexpressed p16 and Ki67.
Measured: 48months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start1 Aug 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer of CervixStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,800 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- University of Fukui
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Yoshio Yoshida, University of Fukui
- Investigators
- Tetsuji Kurokawa, A, Study chair, University of Fukui
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022148
- Sponsor's protocol ID
- C2018001F
- Status last verified
- Jul 2019
- First submitted
- 14 Jul 2019
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kurokawa T, Yamamoto M, Onuma T, Tsuyoshi H, Shinagawa A, Chino Y, Yoshida Y. The study protocol of the evaluation for the preventive efficacy of the HPV vaccine for persistent HPV16/18 infection in Japanese adult women: the HAKUOH study. BMC Cancer. 2020 Nov 3;20(1):1056. doi: 10.1186/s12885-020-07563-0.
PubMed 33143690
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04022148
- Acronym / sponsor ID
- C2018001F
- Conditions
- Cancer of Cervix, Vaccinia
- Keywords
- uterine cervical cancer, HPV vaccine, cancer screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,800 participants (estimated)
- Lead sponsor
- University of FukuiUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 16 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A series of evidence for HPV vaccines has demonstrated the efficacy in young women (Aged less than 26) across the globe. In contrast, limited evidence are available for the efficacy of the quadrivalent HPV6/11/16/18 vaccine in adult women (Aged 27+). Most importantly, evidence for Japanese adult women is not available to date. Nevertheless, , we hypothesize that the quadrivalent HPV6/11/16/18 vaccine demonstrate the efficacy also in Japanese adult women. The outcome from this trial will be the first local evidence, which brings a considerable impact in OB/GY academia where local evidence is weighed heavily compared with global evidence - serves as a strong basis to support catch up program of HPV vaccines for young adults. As a consequence, we believe this study will develop a local supportive evidence for prevention of HPV infection by an HPV vaccine in young adults, which results in substantial public health improvement through prevention of HPV infection in Japan where active recommendation is halted long time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 27 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Japanese adult women (aged 27-45 years) undergo the cervical cancer screening.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnant women
- Undergo treatment or the follow-up evaluation for CIN within the previous 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GardasilExperimental arm: Vaccine group VS Control arm: Non-Vaccine group | Biological | – |
Primary outcome
The rate of the persistent infection
Time frame: 48months
Persistent infection is the cases that the cells from women with HPV16/18 genotype overexpressed p16 and Ki67.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
- Derived from this study: PubMed 33143690Kurokawa T, Yamamoto M, Onuma T, Tsuyoshi H, Shinagawa A, Chino Y, Yoshida Y. The study protocol of the evaluation for the preventive efficacy of the HPV vaccine for persistent HPV16/18 infection in Japanese adult women: the HAKUOH study. BMC Cancer. 2020 Nov 3;20(1):1056. doi: 10.1186/s12885-020-07563-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tetsuji Kurokawa, A study chair
University of Fukui
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of Cervix and Vaccinia, run by University of Fukui.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tetsuji Kurokawa, AP (+81-776-61-8392, kurotetu@u-fukui.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of the persistent infection (time frame: 48months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04022148, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2019.