Clinical trial NCT00602368: Digital Colposcopy in Finding Cervical Intraepithelial Neoplasia
Official title: Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Precancerous Condition
Keywords: cervical cancer
cervical intraepithelial neoplasia grade 1
cervical intraepithelial neoplasia grade 2
cervical intraepithelial neoplasia grade 3
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-01-28
Enrollment: 114
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Feasibility of digital colposcopy & fluorescence spectroscopy as a tool for early diagnosis of CIN
timeFrame: For length of study
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Cancer Research Centre
state: British Columbia
Study officials:
affiliation: British Columbia Cancer Agency, Vancouver General Hospital
name: Dianne M. Miller, M.D.
role: PRINCIPAL_INVESTIGATOR
References: