Pilot project on the use of HPV DNA testing as primary screening test for cervical cancer precursors

Completed

• Conditions: Cervical cancer screening; Cancer; Malignant neoplasm of cervix uteri

• Registration Number: ISRCTN41319771
• Lead Sponsor: CPO Piemonte (Italy)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-25
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 130000

Inclusion Criteria

Women aged 35 to 64 years resident in the relevant areas.

Exclusion Criteria

1. Women previously enrolled in the NTCC trial (ISRCTN81678807)
2. Women unable to provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Compliance to invitation to screening<br>2. Proportion screened of women who test positive to HPV and cytology<br>3. Proportion of screened women referred to new tests<br>4. Referral rate to colposcopy<br>5. Compliance to referral to new tests and to colpscopy <br>6. Positive Predictive value of colposcopy <br>7. Detection rate of histologically confirmed high-grade lesions (CIN2+ and CIN3+)

Secondary Outcome Measures

Name	Time	Method
1. Cost of each screening approach <br>2. Time needed to provide test results<br>3. Anxiety caused a positive test result