Digital Colposcopy in Finding Cervical Intraepithelial Neoplasia in Patients With An Abnormal Pap Smear
Digital Colposcopy in Finding Cervical Intraepithelial Neoplasia in Patients With An Abnormal Pap Smear
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.
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.
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.