Cervical cancer screening trial by randomization of HPV testing intervention for upcoming screening

JRCT ID: jRCTs031180313

Registered date:15/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Cervical cancer
• Date of first enrollment: 01/06/2013
• Target sample size: 30000
• Study type: Interventional
• Intervention(s): The patients were divided into two groups according to stratified randomization, and the factor was regions (Yamanashi prefecture and Kashiwa city).

Outcome(s)

• Primary Outcome: The incidence of CIN3 or worse during whole periods

Secondary Outcome

1) The incidence of CIN3 or worse at baseline, and two years,
four years, and six years post baseline
2) The incidence of CIN2 or worse at baseline, and two years,
four years, and six years post baseline
3) The incidence of CIN1 or worse at baseline, and two years,
four years, and six years post baseline
4) The incidence of invasive cancer at baseline, and two
years, four years, and six years post baseline
5) The number of cervical cytology performance
6) The number of colposcopy and biopsy performance

Key inclusion & exclusion criteria

• Age minimum: >= 30age old
• Age maximum: <= 64age old
• Gender: Female

Include criteria

1) Women aged 30-64 years old.
2) Participants provided written informed consent.

Exclude criteria

1) Women who will receive planed HPV DNA testing by local
governmental cervical cancer program next six years.
2) Women who have had cervical invasive cancer before.
3) Women who have underwent cervical conization.
4) Women who have underwent hysterectomy.
5) Women who have had or have the cytological abnormalities
and are under follow-up.
6) Pregnant women.
7) Women judged ineligible for this trial by physician.

Related Information

• Primary Sponsor: Aoki Daisuke
• Source(s) of Monetary Support: Hologic Japan. Inc,Hologic Japan. Inc,Hologic Japan. Inc,The Japanese Society of Clinical Cytology
• Secondary ID(s): UMIN000010843