Evaluating the Visual Appearance of Cervical Lesions in Relation its Histological Diagnosis, Human Papillomavirus Genotype and Other Viral Parameters: a Prospective Cohort Study
Completed
- Conditions
- Cervical Intraepithelial NeoplasiaCervical lesions10013364
- Registration Number
- NL-OMON41350
- Lead Sponsor
- DDL Diagnostic Laboratory
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
-An abnormal cytological test result
-18 years of age or older
-Written informed consent prior to enrolment
-Sufficient knowledge of the Dutch language
-The intention to comply with the requirements of the protocol
Exclusion Criteria
-History of surgery on the cervix
-Previous pelvic radiotherapy
-Pregnancy or pregnant in the last 3 months
-Actually breast-feeding or breast-feeding in the last 3 months
-Diagnosis of cervix carcinoma
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary study parameters are:<br /><br>- Digitalized colposcopic imaging results<br /><br>- Histological examination data (CIN classification of lesions)<br /><br>- HPV results from LCM isolated lesions<br /><br>- HPV results from entire LEEP/ biopsies</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study parameters are:<br /><br>- HPV results from cervico-vaginal self samples<br /><br>- HPV results from physician-taken cervical scrapes</p><br>