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

July 17, 2014 updated by: British Columbia Cancer Agency

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

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.

Study Overview

Status

Withdrawn

Conditions

Detailed 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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- British Columbia
  - Vancouver, British Columbia, Canada, V5Z 1L3
    - BC Cancer Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Identification of potential improvements for a noninvasive method of diagnosing cervical dysplasia and neoplasia using the Multispectral Digital Colposcope (MDC)
Measurement of MDC images in vivo of the cervix
Effect of the fading of acetic acid in the image contrast obtained over time and its prediction of the grade of intraepithelial neoplasia
Mapping of the cervix and comparison of map with routine colposcopic images as well as with those from the MDC
Comparison of MDC performance with colposcopy and pathologic analysis of tissue removed after colposcopy in the form of the loop electrosurgical excision procedure (LEEP)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

British Columbia Cancer Agency

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: Thomas G Ehlen, M.D., British Columbia Cancer Agency, Vancouver General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (ANTICIPATED)

September 1, 2014

Study Completion (ANTICIPATED)

September 1, 2014

Study Registration Dates

First Submitted

February 7, 2008

First Submitted That Met QC Criteria

February 7, 2008

First Posted (ESTIMATE)

February 8, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 21, 2014

Last Update Submitted That Met QC Criteria

July 17, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CDR0000581295
P01CA082710 (U.S. NIH Grant/Contract)
BCCR-H07-01272 (OTHER: UBC-BCCA REB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.