Changes in the Prevalence of Oncogenic HPV Types

NCT04671823 | Unknown

• 1 other identifier: I547
• Study Type: observational
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

Brief Summary

In Japan, nationwide prophylactic HPV vaccination was implemented in 2010; a bivalent vaccine was given from 2010 to 2012, and a quadrivalent vaccine from 2012. However, the program essentially ceased in June 2013.

1. 1.Our first objective is to examine the prevalence of 6, 11, 16, 18, 31, 33, 45, 52, and 58 targeted by the nonavalent HPV vaccine in young Japanese women, and identify changes in the prevalence of these HPV types from 2011- 2012 (as reported in JHERS-2016; Sasagawa T, J Med Virol, 2016) to the present time (2020-2021). Especially, the investigators will focus on the prevalence of HPV16 and 18 in women aged 21-26 years and compare these data to those of the previous study.
2. 2.The investigators will assess the prevalence of HPV16 and 18 in women aged 16-18 years and compare these data to those of the HPV vaccine era (2010-2013).
3. 3.The investigators will explore the prevalence of other high-risk HPV types (35, 39, 51, 56, 59, and 68), 11 probable high-risk types (26, 30,34, 53, 66, 67, 69, 70, 73, 82, and 85), and SILs in Japanese young women, since these types might be causative HPV types for cervical cancer in the future after world-wide HPV vaccination.

Conditions

Papillomavirus Vaccines; Papillomavirus Infections

Keywords

Human Papillomavirus; Papillomavirus Vaccines; Papillomavirus Infections

Outcome Measures

Primary Outcomes (1)

• The prevalence of HPV types targeted by the nonavalent HPV vaccine

  Our first objective is to examine the prevalence of 6, 11, 16, 18, 31, 33, 45, 52, and 58 targeted by the nonavalent HPV vaccine in young Japanese women, and identify changes in the prevalence of these HPV types from 2011- 2012 (as reported in JHERS-2016; Sasagawa T, J Med Virol, 2016) to the present time (2020-2021). Especially, The investigators will focus on the prevalence of HPV16 and 18 in women aged 21-26 years and compare these data to those of the previous study.

  12 months

Eligibility Criteria

• Age: 16 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Japanese women (aged 16-39 years) who seek cervical cancer screening or gynecological consultations.

You may qualify if:

• Japanese women who seek cervical cancer screening or gynecological consultations
• Women with benign conditions
• year-old
• Women must be sexually experienced, as defined by sexual contact (oral-genital or genital-genital) with at least one male or female partner.

You may not qualify if:

• Women with STDs
• Women with premalignant lesions of the cervicovaginal tract
• Women suffering from any cancer
• Women with any severe acute or chronic disease, and/or psychological problems

Sponsors & Collaborators

• Kanazawa Medical University: lead
• Merck Sharp & Dohme LLC: collaborator

Related Publications (1)

• Sasagawa T, Maehama T, Ideta K, Irie T; Fujiko Itoh J-HERS Study Group. Population-based study for human papillomavirus (HPV) infection in young women in Japan: A multicenter study by the Japanese human papillomavirus disease education research survey group (J-HERS). J Med Virol. 2016 Feb;88(2):324-35. doi: 10.1002/jmv.24323.

  PMID: 26147986 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

This study requires liquid based cytology samples (fixed cells).

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Toshiyuki Sasagawa

CONTACT

+81-76-218-8143; tsasa@kanazawa-med.ac.jp

Mayumi Saito

CONTACT

+81-76-218-8143; m-saito@kanazawa-med.ac.jp

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 17, 2020
• Study Start: December 1, 2020
• Primary Completion: September 30, 2021
• Study Completion: March 31, 2022
• Last Updated: December 23, 2020

Record last verified: 2020-12