Accelerating Cervical Cancer Elimination by Self-Sampling test

JRCT ID: jRCT1030200276

Registered date:25/12/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: cervical cancer
• Date of first enrollment: 22/02/2021
• Target sample size: 20000
• Study type: Interventional
• Intervention(s): Cervical cancer screening wtth self-sampling for HPV test

Outcome(s)

• Primary Outcome: Detection of cervical intraepithelial neoplasia (CIN) 2 or worse

Secondary Outcome

Screening uptake
Subjects who have received cytology test
Subjects required for detaied test
Subjects who have received detailed tests
Detection of CIN2 or worse per one cytology test
Positive predictive values
Incidence of adverse events
Proportion of self-sampling HPV test ordered
Proportion of self-sampking HPV test ordered from the web site
Proportion of self-sampling HPV test received
Proportion of positive HPV test
Proportion of invalid HPV test
Proportion of cytology test received
Time to the self-sampling HPV test ordered
Time to the self-sampling HPV kit sent to the subjects
Time to the self-sampling HPV kit returned from the subjects
Time to HPV test ordered to the laboratory
TIme to HPV test result reported from the laboratory
Time to HPV test result sent to the subjects
Total time
Questionnaire survey
Screening uptake in 2023

Key inclusion & exclusion criteria

• Age minimum: >= 30age old
• Age maximum: < 60age old
• Gender: Female

Include criteria

1. Female residents of Ichihara City at the time of extraction
2. Target residents for cervical cancer screening in the fiscal year 2021 (even-numbered age)
3. Residents aged 30 years to 59 years at the point of April 1 in 2021
4. Residents who have not participated in the screening by Ichihara City for more than three years

• Exclude criteria: 1. Residents with unknown address

Related Information

• Primary Sponsor: Hata Akira
• Source(s) of Monetary Support: Japan Society for the Promotion of Science