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
Recruitment status was Recruiting
Sponsor:
British Columbia Cancer Agency
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
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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) |
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 May 19, 2013