Simplified monitoring of post-treatment CIN2/3 women by molecular testing for hrHPV and methylation markers
Completed
- Conditions
- CINpremalignant cervical disease10013364
- Registration Number
- NL-OMON39503
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 360
Inclusion Criteria
-A histological confirmed CIN2/3 lesion that will be treated by cone biopsy or colposcopic guided LLETZ.
- Written informed consent prior to enrolment.
- Sufficient knowledge of the Dutch language.
- A minimum age of 18 years.
-The intention to comply with the requirements of the protocol.
Exclusion Criteria
-The subject is pregnant (or has been in the last three months)
-The subject has received prophylactic (or therapeutic) HPV- vaccination.
-The subject has a diagnosis of carcinoma in cone biopsy or colposcopic guided LLETZ
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the histological confirmed recurrence of a<br /><br>high-grade lesion in the study population from the moment of treatment until<br /><br>exit-colposcopy</p><br>
- Secondary Outcome Measures
Name Time Method