A randomized control trial to evaluate effectiveness of self sampling HPV test

2023 Fiscal Year Final Research Report

• Project/Area Number: 20H03906
• Research Category: Grant-in-Aid for Scientific Research (B)
• Allocation Type: Single-year Grants
• Section: 一般
• Review Section: Basic Section 58010:Medical management and medical sociology-related
• Research Institution: Chiba University
• Principal Investigator: Hata Akira 千葉大学, 予防医学センター, 特任教授 (00244541)
• Project Period (FY): 2020-04-01 – 2024-03-31
• Keywords: 子宮頸がん検診 / 自己採取HPV－DNA検査 / ランダム化比較試験

Outline of Final Research Achievements

This is the first randomized controlled trial to evaluate the effectiveness of self-sampling HPV test in Japan. Women assigned to the intervention group (n=7,337) could undergo the regular screening (cytology) or screening with self-sampling HPV test and those to the control group (n=7,772) the regular screening. Screening uptake in the intervention and control groups were 20.0% and 6.0%, respectively, and significant difference was observed. Compliance rate with cytology triage in HPV-positive women was 46.8%. Self-sampling HPV test increased screening uptake; however, no difference was observed in the detection of CIN2+ between the two groups, probably due to a low compliance rate with cytology triage. Further research is needed to identify effective strategies to ensure an adequate compliance rate before rolling out programs that include self-sampling at the national level.

Free Research Field

公衆衛生学、人類遺伝学

Academic Significance and Societal Importance of the Research Achievements

子宮頸がんは、HPVワクチン接種と検診で予防可能な疾患であるが、我が国の予防対策は十分ではない。自己採取HPV検査は、検診受診率を向上させ、早期がんや前がん病変の検出を増加させる可能性があるが、その有効性が評価されていなかった。本研究は、自己採取HPV検査が検診受診率を向上させることを明らかにした我が国初めてのランダム化比較研究である。しかし、一方で、HPV陽性者の細胞診トリアージ検査受診率が低く、早期がんや前がん病変の検出の向上には至らなかった。自己採取HPV検査を実装するにあたっての課題が明確となった。