Fluorescence and reflectance spectroscopic imaging scan for detection of cervical neoplasia
Completed
- Conditions
- Cervical intraepithelial neoplasiaprecancerous cervical cells10013364
- Registration Number
- NL-OMON41942
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 152
Inclusion Criteria
Age >=18 years
Requiring colposcopic evaluation or requiring control pap-smear after previous treatment or with a watchful waiting policy
Exclusion Criteria
Currenty pregnant or pregnancy in the last 3 months
Currently undergoing treatment for cervical cancer
Current menstruation
Previous pelvic radiotherapy
High-grade cervical smear
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameters are sensitivity, specificity, positive predictive<br /><br>value and negative predictive value of the multimodal hyperspectroscopy<br /><br>cervical scan to detect high grade cervical intraepithelial neoplasia. The<br /><br>result of the cervical scan will be compared to the result of the hrHPV test. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secundary study parameters are: ease of use of the cervical scan and adverse<br /><br>events of the scan for the patient. Duration of the scan and additional time<br /><br>needed for the appointment because of the scan will also be evaluated.</p><br>