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
  Purpose

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.


Condition Intervention Phase
Cervical Cancer
Precancerous Condition
Procedure: colposcopic biopsy
Procedure: colposcopy
Procedure: light-scattering spectroscopy
Procedure: loop electrosurgical excision procedure
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Pilot Study: Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia Using a Second Generation Device

Resource links provided by NLM:


Further study details as provided by British Columbia Cancer Agency:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: October 2010
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00610662

Locations
Canada, British Columbia
BC Cancer Research Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 1L3
Contact: Sylvia Lam    604-675-8093      
Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
Principal Investigator: Thomas G Ehlen, M.D. BC Cancer Agency, Vancouver General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Sylvia Lam, research assistant, BCCA
ClinicalTrials.gov Identifier: NCT00610662     History of Changes
Other Study ID Numbers: CDR0000581295, BCCR-H07-01272, P01CA082710
Study First Received: February 7, 2008
Last Updated: November 3, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by British Columbia Cancer Agency:
cervical cancer
cervical intraepithelial neoplasia grade 1
cervical intraepithelial neoplasia grade 2
cervical intraepithelial neoplasia grade 3

Additional relevant MeSH terms:
Neoplasms
Uterine Cervical Neoplasms
Precancerous Conditions
Cervical Intraepithelial Neoplasia
Carcinoma in Situ
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on April 15, 2014