Digital Colposcopy in Finding Cervical Intraepithelial Neoplasia

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00602368

Enrollment

114

Registered

2008-01-28

Start date

2010-12-31

Completion date

2015-05-31

Last updated

2017-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer, Precancerous Condition

Keywords

cervical cancer, cervical intraepithelial neoplasia grade 1, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3

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.

Interventions

OTHERhistological technique

OTHERlaboratory biomarker analysis

PROCEDUREcolposcopic biopsy

PROCEDUREcolposcopy

PROCEDURElight-scattering spectroscopy

PROCEDUREloop electrosurgical excision procedure

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026