HPV test and post-treatment and long term follow up
- Conditions
- Cervical Intraepithelial neoplasia (CIN), Human Papillomavirus (HPV), post-treatment, long term, recurrence, recidive In Dutch: (pre)maligne afwijkingen cervix,CIN, Humaan papillomavirus (HPV), post-treatment, lange termijn, recidief
- Registration Number
- NL-OMON29304
- Lead Sponsor
- HUMAVAC (VU University Medical Center)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 440
Inclusion Criteria
All subjects must satisfy the following criteria at study entry:
1. Previous participation in one of the following studies: Addition of high-risk HPV testing improves the current guidelines on follow-up after treatment for Cervical Intraepithelial Neoplasia”, conducted by Nobbenhuis et al., Condom use promotes regression of cervical intraepithelial neoplasia and clearance of human papillomavirus: a randomized clinical trial” conducted by Hogewoning et al., or Post treatment CIN: Randomized Clinical Trial using hrHPV testing for prediction of residual/ recurrent disease ”, conducted by Bais et al.
Exclusion Criteria
1. Pregnancy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number of histological confirmed cases of high-grade disease (including CIN 2/3, AIS and VaIN 2/3), diagnosed after a follow up period of up to 18 years after treatment.
- Secondary Outcome Measures
Name Time Method Secondary study outcomes include: <br /><br>- The results of cervical cytology.<br /><br>- The presence of hrHPV.<br /><br>- Type of hrHPV. <br /><br>- The results of the questionnaire (including sexual behavior, smoking and previous vaccination).<br /><br>- The results of revision and hrHPV testing of all positively identified subjects who have received a cervical treatment (including hysterectomy) in the period between the last visit of the previous study and the current study.<br /><br>- Histology results of all endocervix samples and biopsies taken.<br />