This trial is active, not recruiting.

Conditions cervical cancer, precancerous condition
Treatments histological technique, laboratory biomarker analysis, colposcopic biopsy, colposcopy, light-scattering spectroscopy, loop electrosurgical excision procedure
Sponsor British Columbia Cancer Agency
Collaborator National Cancer Institute (NCI)
Start date December 2010
End date December 2014
Trial size 114 participants
Trial identifier NCT00602368, BCCR-H03-61235, CDR0000581286, P01CA082710


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic

Primary Outcomes

Feasibility of digital colposcopy & fluorescence spectroscopy as a tool for early diagnosis of CIN
time frame: For length of study

Eligibility Criteria

Female participants at least 19 years old.

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

Additional Information

Official title Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia: A Pilot Study
Principal investigator Dianne M. Miller, M.D.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by British Columbia Cancer Agency.