Comparing the value of HPV transcript analysis and analysis of DNA methylation status for stratification of high-risk HPV positive women for risk of developing high grade cervical intraepithelial neoplasia (CIN) lesions and cervical carcinoma, to that of conventional cytology.
Completed
- Conditions
- cervical cancercervical intraepithelial neoplasma10038594
- Registration Number
- NL-OMON37087
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 300
Inclusion Criteria
Women between 20-70 years of age
Cervical smear is high-risk HPV DNA positive
cervix intact (no history of surgical treatment involving damage to transformation zone of cervix)
Exclusion Criteria
Women unable to take a vaginal self-sample
Cervical smear is hr-HPV DNA negative
(previous) abnormal cervical smear of at least BMD (pap3a2) or cervical cancer within preceding 2 years
presents of any cancer but cervical cancer
history of surgery on cervix
Pregnancy or having been pregnant (equally for breast-feeding) in the last 3 months
heavy vaginal bleeding
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Endpoint is histology outcome; i.e. presence or absence of *CIN2 lesions. The<br /><br>short-term risk of *CIN2 will be assessed as a function of E7 transcript and<br /><br>DNA methylation status. The sensitivity, specificity, positive and negative<br /><br>predictive values of mRNA testing and analysis of DNA promoter methylation for<br /><br>detection of *CIN2 lesions in hr-HPV positive women will be determined and<br /><br>compared to that of cytology.</p><br>
- Secondary Outcome Measures
Name Time Method <p>not applicable</p><br>