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

JRCT ID: jRCT1030240280

Registered date:20/08/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: cervical cancer
• Date of first enrollment: 20/08/2024
• Target sample size: 5000
• Study type: Interventional
• Intervention(s): Cervical abrasion and colposcopy

Outcome(s)

• Primary Outcome: 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: 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

Key inclusion & exclusion criteria

• Age minimum: >= 30age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

1) 30 years of age or older
2) Less than 17 weeks pregnant

Exclude 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.

Related Information

• Primary Sponsor: Mizushima Taichi
• Secondary Sponsor: Miyagi Etsuko
• Source(s) of Monetary Support: SHIONOGI INFECTIOUS DISEASE RESEARCH PROMOTION FOUNDATION