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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by British Columbia Cancer Agency.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT00610662
First received: February 7, 2008
Last updated: November 3, 2010
Last verified: November 2010

February 7, 2008
November 3, 2010
October 2010
March 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00610662 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Digital Colposcopy in Finding Cervical Intraepithelial Neoplasia in Patients With An Abnormal Pap Smear
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.

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.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Cervical Cancer
  • Precancerous Condition
  • Procedure: colposcopic biopsy
  • Procedure: colposcopy
  • Procedure: light-scattering spectroscopy
  • Procedure: loop electrosurgical excision procedure
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
November 2011
March 2011   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Not Provided
Canada
 
NCT00610662
CDR0000581295, BCCR-H07-01272, P01CA082710
No
Sylvia Lam, research assistant, BCCA
British Columbia Cancer Agency
National Cancer Institute (NCI)
Principal Investigator: Thomas G Ehlen, M.D. BC Cancer Agency, Vancouver General Hospital
British Columbia Cancer Agency
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP