Cervical intraepithelial neoplasia precancerous cervical cells
Conditions
Interventions
Patients will undergo a, one minute, spectroscopic cervical vaginal scan,
performed by a healthcare worker in the outpatient clinic. Also an additional
hrHPV test with genotyping will be performed o
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age >=18 years Requiring colposcopic evaluation or requiring control pap-smear after previous treatment or with a watchful waiting policy
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters are sensitivity, specificity, positive predictive value and negative predictive value of the multimodal hyperspectroscopy cervical scan to detect high grade cervical intraepithelial neoplasia. The result of the cervical scan will be compared to the result of the hrHPV test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary study parameters are: ease of use of the cervical scan and adverse events of the scan for the patient. Duration of the scan and additional time needed for the appointment because of the scan will also be evaluated. | — |
Countries
Netherlands
Outcome results
None listed