NCT00602368

Digital Colposcopy in Finding Cervical Intraepithelial Neoplasia

Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia: A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: British Columbia Cancer Agency · Academic / Other
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Cervical Cancer
• Precancerous Condition

Interventions

Type	Name	Description
OTHER	histological technique
OTHER	laboratory biomarker analysis
PROCEDURE	colposcopic biopsy
PROCEDURE	colposcopy
PROCEDURE	light-scattering spectroscopy
PROCEDURE	loop electrosurgical excision procedure

Timeline

• Start date: 2010-12-01
• Primary completion: 2014-12-01
• Completion: 2015-05-01
• First posted: 2008-01-28
• Last updated: 2017-02-01

Locations

1 site across 1 country: Canada