ew Technologies for Cervical Cancer screening
Completed
- Conditions
- Cervical cancerCancer
- Registration Number
- ISRCTN81678807
- Lead Sponsor
- CPO Piemonte (Italy)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 94000
Inclusion Criteria
Women 25 to 60 years old coming for a new screening episode in nine organised cervical screening programmes
Exclusion Criteria
1. Virgin
2. Pregnant
3. Hysterectomised
4. Treated for cervical cancer or intraepithelial lesions in last five years
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measure is the detection rate (DR) of histologically confirmed cervical intraepithelial neoplasia grade 2 or more severe (CIN2+). In order to test the study hypothesis we will consider DR of CIN2+ after recruitment and up to including re-screening among women who tested negative at recruitment. The DR of CIN2+ at recruitment will be studied in order to investigate the cross sectional sensitivity of new technologies compared to conventional cytology (hypothesis: higher DR in experimental arm). The overall DR at recruitment and up to including re-screening in the two arms will be compared in order to study the relative over-diagnosis of regressive lesions.
- Secondary Outcome Measures
Name Time Method Main secondary outcome measures are the referral rate to colposcopy and the positive predictive value for CIN2+ in the two study arms.