Digital Colposcopy in Finding Cervical Intraepithelial Neoplasia

British Columbia Cancer Agency

Status: Completed

Conditions: Precancerous Condition; Cervical Cancer

Treatments: Other: histological technique; Procedure: loop electrosurgical excision procedure; Other: laboratory biomarker analysis; Procedure: light-scattering spectroscopy; Procedure: colposcopy; Procedure: colposcopic biopsy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00602368

P01CA082710 (U.S. NIH Grant/Contract)

CDR0000581286

BCCR-H03-61235 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)