Digital Colposcopy in Finding Cervical Intraepithelial Neoplasia

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

Official Title
-----------------
Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia: A Pilot Study

Conditions
-----------------
Cervical Cancer, Precancerous Condition

Intervention / Treatment
-----------------
* Other: histological technique
* Other: laboratory biomarker analysis
* Procedure: colposcopic biopsy
* Procedure: colposcopy
* Procedure: light-scattering spectroscopy
* Procedure: loop electrosurgical excision procedure


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: histological technique|nan|
|Other: laboratory biomarker analysis|nan|
|Procedure: colposcopic biopsy|nan|
|Procedure: colposcopy|nan|
|Procedure: light-scattering spectroscopy|nan|
|Procedure: loop electrosurgical excision procedure|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of digital colposcopy & fluorescence spectroscopy as a tool for early diagnosis of CIN | Measure normal and abnormal sites during colposcopy and compare this to pathology. | For length of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cervical cancer, cervical intraepithelial neoplasia grade 1, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3