Digital Colposcopy in Finding Cervical Intraepithelial Neoplasia
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.
Other: histological technique
Other: laboratory biomarker analysis
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:||Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia: A Pilot Study|
- Feasibility of digital colposcopy & fluorescence spectroscopy as a tool for early diagnosis of CIN [ Time Frame: For length of study ] [ Designated as safety issue: No ]Measure normal and abnormal sites during colposcopy and compare this to pathology.
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||January 2016|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00602368
|Canada, British Columbia|
|BC Cancer Research Centre|
|Vancouver, British Columbia, Canada, V5Z 1L3|
|Principal Investigator:||Dianne M. Miller, M.D.||British Columbia Cancer Agency, Vancouver General Hospital|