Cervical Cancer, Precancerous Condition
Conditions
Keywords
cervical cancer, cervical intraepithelial neoplasia grade 1, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3
Brief summary
RATIONALE: Diagnostic procedures, such as digital colposcopy, may help doctors find and diagnose cervical intraepithelial neoplasia. PURPOSE: This clinical trial is studying digital colposcopy to see how well it works in finding cervical intraepithelial neoplasia in patients with an abnormal Pap smear.
Detailed description
OBJECTIVES: * To identify potential improvements for a noninvasive method of diagnosing cervical dysplasia and neoplasia using the Multispectral Digital Colposcope (MDC), a device that uses fluorescence and reflectance spectroscopy to compare images with histopathologic mapping of the cervical epithelium. * To measure MDC images in vivo of the cervix using a modified device that makes measurements in seconds rather than over 2 minutes before and after acetic acid. * To evaluate, preliminarily, the effect of the fading of acetic acid in the image contrast obtained over time to see if this fading can predict the grade of intraepithelial neoplasia. * To evaluate mapping of the cervix so that software can reconstruct the cervical epithelial map to compare the map with routine colposcopic images as well as with those from the MDC. * To compare, preliminarily, MDC performance with colposcopy and pathologic analysis of tissue removed after colposcopy in the form of the loop electrosurgical excision procedure (LEEP). OUTLINE: This is a multicenter study. Patients undergo routine colposcopy as part of their regular colposcopic evaluation. The digital colposcope is used to take images of the vagina and cervix, pre- and post-acetic acid, using white, green, and blue light. Colposcopically abnormal areas are biopsied; a normal area may also be biopsied. Patients undergoing loop electrosurgical excision procedure (LEEP) may undergo one additional biopsy of a colposcopically normal site.
Interventions
None listed
Sponsors
National Cancer Institute (NCI)
British Columbia Cancer Agency
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Criteria Inclusion criteria: * Included subjects will be ≥18 years old. * Included subjects will not be pregnant. * Included subjects will have a negative urine pregnancy test. * Included subjects will be scheduled for colposcopy and/or LEEP treatment at the VGH Women's Clinic. * Included subjects will indicate understanding of the study. * Included subjects will provide informed consent to participate.
Exclusion criteria
* Individuals \<18 years old will be excluded. * Pregnant individuals will be excluded. * Individuals that have had an operation to remove their cervix will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identification of potential improvements for a noninvasive method of diagnosing cervical dysplasia and neoplasia using the Multispectral Digital Colposcope (MDC) | — |
| Measurement of MDC images in vivo of the cervix | — |
| Effect of the fading of acetic acid in the image contrast obtained over time and its prediction of the grade of intraepithelial neoplasia | — |
| Mapping of the cervix and comparison of map with routine colposcopic images as well as with those from the MDC | — |
| Comparison of MDC performance with colposcopy and pathologic analysis of tissue removed after colposcopy in the form of the loop electrosurgical excision procedure (LEEP) | — |
Countries
Canada
Outcome results
None listed