Digital Colposcopy in Finding Cervical Intraepithelial Neoplasia in Patients With An Abnormal Pap Smear

Cervical Cancer Clinical Trial

Official title:

A Pilot Study: Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia Using a Second Generation Device

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00610662
• Other study ID #: CDR0000581295
• Secondary ID: BCCR-H07-01272P0
• Status: Withdrawn
• Phase: Phase 1
• First received: February 7, 2008
• Last updated: July 17, 2014
• Start date: December 2010
• Est. completion date: September 2014

Study information

• Verified date: April 2014
• Source: British Columbia Cancer Agency
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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 in patients with an abnormal Pap smear.

Description:

OBJECTIVES:

• 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Criteria

Inclusion criteria:

• Included subjects will be =18 years old.

• Included subjects will not be pregnant.

• Included subjects will have a negative urine pregnancy test.

• Included subjects will be scheduled for colposcopy and/or LEEP treatment at the VGH Women's Clinic.

• Included subjects will indicate understanding of the study.

• Included subjects will provide informed consent to participate.

Exclusion criteria:

• Individuals <18 years old will be excluded.

• Pregnant individuals will be excluded.

• Individuals that have had an operation to remove their cervix will be excluded.

Study Design

N/A

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Cancer
• Cervical Intraepithelial Neoplasia
• Precancerous Condition
• Precancerous Conditions
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
Canada	BC Cancer Research Centre	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
British Columbia Cancer Agency	National Cancer Institute (NCI)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of potential improvements for a noninvasive method of diagnosing cervical dysplasia and neoplasia using the Multispectral Digital Colposcope (MDC)			No
Primary	Measurement of MDC images in vivo of the cervix			No
Primary	Effect of the fading of acetic acid in the image contrast obtained over time and its prediction of the grade of intraepithelial neoplasia			No
Primary	Mapping of the cervix and comparison of map with routine colposcopic images as well as with those from the MDC			No
Primary	Comparison of MDC performance with colposcopy and pathologic analysis of tissue removed after colposcopy in the form of the loop electrosurgical excision procedure (LEEP)			No