Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia: A Pilot Study
19 Years
N/A
Female
Cervical Cancer, Precancerous Condition
Trial Information
Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia: A Pilot Study
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Principal Investigator
Thomas G Ehlen, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
BC Cancer Agency, Vancouver General Hospital
Authority:
United States: Institutional Review Board
Study ID:
CDR0000581286
NCT ID:
NCT00602368
Start Date:
December 2010
Completion Date:
September 2014
Related Keywords:
- Cervical Cancer
- Precancerous Condition
- cervical cancer
- cervical intraepithelial neoplasia grade 1
- cervical intraepithelial neoplasia grade 2
- cervical intraepithelial neoplasia grade 3
- Neoplasms
- Uterine Cervical Neoplasms
- Precancerous Conditions
- Cervical Intraepithelial Neoplasia
- Carcinoma in Situ
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