Digital Colposcopy in Finding Cervical Intraepithelial Neoplasia
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:
NCT00602368
First received: January 25, 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.
| Condition | Intervention |
|---|---|
|
Cervical Cancer Precancerous Condition |
Other: histological technique Other: laboratory biomarker analysis Procedure: colposcopic biopsy Procedure: colposcopy Procedure: light-scattering spectroscopy Procedure: loop electrosurgical excision procedure |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia: A Pilot Study |
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 digital colposcopy and fluorescence spectroscopic imaging [ Designated as safety issue: No ]
- Measurement of fluorescence and reflectance images of the human cervix in vivo using digital colposcopy [ Designated as safety issue: No ]
- Effect of acetic acid on the image contrast [ Designated as safety issue: No ]
- Comparison of device performance with colposcopic impression and histopathologic interpretation of tissue removed by standard loop electrosurgical excision procedure (LEEP) [ Designated as safety issue: No ]
| Estimated Enrollment: | 114 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | August 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 digital colposcopy and fluorescence spectroscopic imaging.
- To measure fluorescence and reflectance images of the human cervix in vivo using digital colposcopy.
- To evaluate the effect of acetic acid on the image contrast obtained.
- To compare the device performance with colposcopic impression and histopathologic interpretation of tissue removed by standard loop electrosurgical excision procedure (LEEP).
OUTLINE: This is a multicenter study.
Participants undergo routine colposcopy as part of their regular colposcopic evaluation. The digital colposcope is used to take fluorescence and reflectance images of the vagina and cervix. Participants also undergo loop electrosurgical excision procedure (LEEP). The digital colposcopic images are compared with tissue removed during LEEP. Additional surrogate biomarkers under development are also measured using tissue samples removed during LEEP, such as quantitative histopathology measurements, DNA tests for the copy number changes, and tests for the incorporation of viral HPV DNA.
Eligibility| Ages Eligible for Study: | 19 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.
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00602368
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: | NCT00602368 History of Changes |
| Other Study ID Numbers: | CDR0000581286, BCCR-H03-61235, P01CA082710 |
| Study First Received: | January 25, 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 16, 2013