Cervical Cancer Clinical Trial
Official title:
Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia: A Pilot Study
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.
OBJECTIVES:
- To identify potential improvements for a noninvasive method of diagnosing cervical
dysplasia and neoplasia using digital colposcopy and fluorescence spectroscopic
imaging.
- To measure fluorescence and reflectance images of the human cervix in vivo using
digital colposcopy.
- To evaluate the effect of acetic acid on the image contrast obtained.
- To compare the device performance with colposcopic impression and histopathologic
interpretation of tissue removed by standard loop electrosurgical excision procedure
(LEEP).
OUTLINE: This is a multicenter study.
Participants undergo routine colposcopy as part of their regular colposcopic evaluation. The
digital colposcope is used to take fluorescence and reflectance images of the vagina and
cervix. Participants also undergo loop electrosurgical excision procedure (LEEP). The
digital colposcopic images are compared with tissue removed during LEEP. Additional
surrogate biomarkers under development are also measured using tissue samples removed during
LEEP, such as quantitative histopathology measurements, DNA tests for the copy number
changes, and tests for the incorporation of viral HPV DNA.
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