Digital Colposcopy in Finding Cervical Intraepithelial Neoplasia

Not Applicable

Completed

• Conditions: Precancerous Condition; Cervical Cancer

• Registration Number: NCT00602368
• Lead Sponsor: British Columbia Cancer Agency

Brief 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.

Study Timeline

• Study First Submitted: 2008-01-25
• Study First Submitted QC: 2008-01-25
• Study First Posted: 2008-01-28
• Study Start: 2010-12
• Primary Completion: 2014-12
• Study Completion: 2015-05
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 114

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of digital colposcopy & fluorescence spectroscopy as a tool for early diagnosis of CIN	For length of study	Measure normal and abnormal sites during colposcopy and compare this to pathology.

Trial Locations

Locations (1)

BC Cancer Research Centre; 🇨🇦 Vancouver, British Columbia, Canada