臨床研究等提出・公開システム

Japanese

Date of registration	Aug. 20, 2024
Last modified on	June. 05, 2026
Trial ID	jRCT1030240280

Scientific Title	A Single-Arm Comparison Study with Cervical Cytology to Evaluate the Efficacy of HPV Screening in Pregnant Women
Public Title	A Single-Arm Comparison Study with Cervical Cytology to Evaluate the Efficacy of HPV Screening in Pregnant Women

Contact for Scientific Queries	Name	Mizushima Taichi
	Affiliation	Yokohama City University Hospital
	Address	3-9 Fukuura, Kanazawa, Yokohama, Kanagawa
	Telephone	+81-45-787-2800
	E-mail	tmizushi@yokohama-cu.ac.jp
Contact for Public Queries	Name	Mizushima Taichi
	Affiliation	Yokohama City University Hospital
	Address	3-9 Fukuura, Kanazawa, Yokohama, Kanagawa
	Telephone	+81-45-787-2800
	E-mail	tmizushi@yokohama-cu.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Aug. 20, 2024
Actual date of first enrollment		Oct. 29, 2024
Target sample size		5000
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	active control
	assignment	single assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) 30 years of age or older 2) Less than 17 weeks pregnant
	Exclusion Criteria	1) No cervix 2) Undergoing treatment or history of invasive cancer of the cervix 3) Undergoing treatment or follow-up at a medical institution for precancerous lesion of the cervix or suspected precancerous lesion of the cervix 4) Other cases in which the subject is judged to be inappropriate by the physician's judgment.
	Age Minimum	30age old over
	Age Maximum	No limit
	Gender	Female
Health Condition(s) or Problem(s) Studied		cervical cancer
Intervention(s)		Cervical abrasion and colposcopy
Health Condition(s) Keyword		pregnant woman, cervical cancer, HPV screening, cytology screening
Intervention(s) Keyword		cervical abrasion, colposcopy
Primary Outcome(s)		To test the non-inferiority of HPV screening to cytology screening for the detection rate of CIN2+ immediately after early pregnancy testing using a mathematical statistical model.
Secondary Outcome(s)		Descriptive statistics (background of target population), comparison of lesion detection rates between cytology and HPV screening, comparison by age group, comparison of risk of lesion progression by HPV subtype, HPV positivity rate at 1 year, comparison between testing methods, comparison of risk of lesion progression in cytology positive cases, rate of definitive results for testing methods, prognosis for each group classified as early pregnancy Assessment of adverse reactions

Primary Sponsor	Yokohama City University Hospital Obstetrics and Gynecology

Secondary Sponsor

Source of Monetary Support	SHIONOGI INFECTIOUS DISEASE RESEARCH PROMOTION FOUNDATION
Secondary Sponsor	Not applicable

Name of Certified Review Board	Yokohama City University Ethics Committee
Address	3-9 Fukuura Kanazawa-ku, Yokohama city, Kanagawa, Kanagawa
Telephone	+81-45-370-7627
E-Mail	rinri@yokohama-cu.ac.jp
Approval Status	Approval
Date of approval	July. 25, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
7	June. 05, 2026	(this page)	Changes
6	Mar. 23, 2026	Detail	Changes
5	Mar. 18, 2026	Detail	Changes
4	Feb. 26, 2026	Detail	Changes
3	Jan. 09, 2026	Detail	Changes
2	Feb. 26, 2025	Detail	Changes
1	Aug. 20, 2024	Detail

List of change history