Digital Colposcopy in Finding Cervical Intraepithelial Neoplasia
NCT ID: NCT00602368
Last Updated: 2017-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
114 participants
INTERVENTIONAL
2010-12-31
2015-05-31
Brief Summary
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PURPOSE: This clinical trial is studying digital colposcopy to see how well it works in finding cervical intraepithelial neoplasia.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Interventions
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histological technique
laboratory biomarker analysis
colposcopic biopsy
colposcopy
light-scattering spectroscopy
loop electrosurgical excision procedure
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnant individuals will be excluded.
* Individuals that have had an operation to remove their cervix will be excluded.
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
19 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
British Columbia Cancer Agency
OTHER
Responsible Party
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Principal Investigators
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Dianne M. Miller, M.D.
Role: PRINCIPAL_INVESTIGATOR
British Columbia Cancer Agency, Vancouver General Hospital
Locations
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BC Cancer Research Centre
Vancouver, British Columbia, Canada
Countries
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Other Identifiers
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BCCR-H03-61235
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000581286
Identifier Type: -
Identifier Source: org_study_id
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