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Digital Colposcopy in Finding Cervical Intraepithelial Neoplasia

2014-08-27 03:33:27 | BioPortfolio

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.

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.

Study Design

Primary Purpose: Diagnostic

Conditions

Cervical Cancer

Intervention

histological technique, laboratory biomarker analysis, colposcopic biopsy, colposcopy, light-scattering spectroscopy, loop electrosurgical excision procedure

Location

BC Cancer Research Centre
Vancouver
British Columbia
Canada
V5Z 1L3

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:33:27-0400

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