a retrospective longitudinal clinical cohort study to investigate HPV testing post-treatment and the risk of recurrence of (cervical) disease on the long term.
Phase 4
Recruiting
- Conditions
- cervical cancerCIN1003859710013364
- Registration Number
- NL-OMON32424
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 445
Inclusion Criteria
All subjects must satisfy the following criteria at study entry:
- Previous participation in one of the studies, described in section study population
- Written informed consent prior to enrolment.
- Sufficient knowledge of the Dutch or English language.
- The intention to comply with the requirements of the protocol.
Exclusion Criteria
Pregnancy (or delivered within three months)
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the number of histological confirmed cases of<br /><br>high-grade disease (including CIN 2/3, AIS and VaIN 2/3), diagnosed after a<br /><br>follow-up period of up to 18 years after treatment for a high-grade cervical<br /><br>lesion (CIN 2/3).</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary study parameters include:<br /><br>- the results of cervical cytology<br /><br>- the presence of hrHPV<br /><br>- the type of hrHPV<br /><br>- the results of the questionnaire (including sexual behavior, smoking and<br /><br>previous vaccination)<br /><br>- the histological results of all endocervical samples and biopsies taken in<br /><br>the study and revision and additional hrHPV testing of all interval lesions<br /><br>in between the index study and the current study.</p><br>