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

Pilot project on the use of HPV DNA testing as primary screening test for cervical cancer precursors: A multicentre randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN41319771

Enrollment

130000

Registered

2010-03-25

Start date

2010-03-22

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical cancer screening Cancer Malignant neoplasm of cervix uteri

Interventions

Intervention arm. Women will have two cervical samples taken, first one for a conventional cytological smear (by Ayre?s spatula and cytobrush) and one for HPV testing (by brush). Initially only the H

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
1. Cost of each screening approach 2. Time needed to provide test results 3. Anxiety caused a positive test result	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026