Digital Colposcopy in Finding Cervical Intraepithelial Neoplasia in Patients With An Abnormal Pap Smear
Recruitment status was Recruiting
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.
Procedure: colposcopic biopsy
Procedure: light-scattering spectroscopy
Procedure: loop electrosurgical excision procedure
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Pilot Study: Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia Using a Second Generation Device|
- Identification of potential improvements for a noninvasive method of diagnosing cervical dysplasia and neoplasia using the Multispectral Digital Colposcope (MDC) [ Designated as safety issue: No ]
- Measurement of MDC images in vivo of the cervix [ Designated as safety issue: No ]
- Effect of the fading of acetic acid in the image contrast obtained over time and its prediction of the grade of intraepithelial neoplasia [ Designated as safety issue: No ]
- Mapping of the cervix and comparison of map with routine colposcopic images as well as with those from the MDC [ Designated as safety issue: No ]
- Comparison of MDC performance with colposcopy and pathologic analysis of tissue removed after colposcopy in the form of the loop electrosurgical excision procedure (LEEP) [ Designated as safety issue: No ]
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||November 2011|
|Estimated Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
- 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.
|Canada, British Columbia|
|BC Cancer Research Centre||Recruiting|
|Vancouver, British Columbia, Canada, V5Z 1L3|
|Contact: Sylvia Lam 604-675-8093|
|Principal Investigator:||Thomas G Ehlen, M.D.||BC Cancer Agency, Vancouver General Hospital|