Clinical Evaluation of Polarized Light Assisted Colposcopy

This is a prospective study to compare unpolarized (conventional) to polarized light colposcopy. Subjects will be asked to participate in the study when they arrive for their prescheduled colposcopic examination. The study doctor will use a conventional or standard colposcope to perform the examination. His/her impression of the exam will be noted and if necessary a biopsy specimen will be obtained. The study doctor will then perform a colposcopy using a polarized light. His/her impression of the exam will be noted and a biopsy specimen will be obtained if necessary.

This study is designed to test the hypothesis that polarized light colposcopy is more sensitive and more specific than standard, un-polarized light colposcopy.

Study Overview

• Status: Completed
• Conditions: Cervical Intraepithelial Neoplasia

Detailed Description

Women scheduled for a colposcopic examination at GRU or CerviCusco were asked to participate in the study. Interested patients read and signed an IRB-approved Informed Consent Document (ICD) that described the study and their potential involvement. The study coordinator read and or translated the ICD to women who spoke languages other than English or Spanish (i.e. Quechua).

Pertinent disease specific demographic information was collected from each patient. Following insertion of a vaginal speculum and a one minute application of 5% acetic acid, polarized and non-polarized high resolution digital RGB images were taken of the ectocervix. Thereafter, non-polarized light colposcopy was performed as standard of care. The colposcopist derived a colposcopic impression and indicated whether a biopsy was necessary. So as not to compromise the next examination, Lugol's Iodine was not applied. Then, a polarized light colposcopy was performed. As before, the colposcopist derived an impression, indicated whether a biopsy was necessary and annotated the site of pending biopsy. Then if indicated, a minimum of one cervical biopsy was obtained from the area(s) representing the most severe colopscopic changes as seen during the non-polarized exam. The exact biopsy site was annotated.

• Study Type: Observational
• Enrollment (Actual): 330

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Georgia Health Sciences University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Healthy women with a previously detected abnormal cervical cytology or other indication for colposcopy

Description

Inclusion Criteria:

• Subject is female, 18 years or older
• Subject has previously detected abnormal cervical cytology or other indication for colposcopy
• Subject fully understands study procedures, alternative treatments available, the risks involved with the study, and voluntarily agrees to participate by giving written informed consent

Exclusion Criteria:

• Subject is pregnant or may be pregnant
• Subject has known allergy to acetic acid
• Subject has thrombocytopenia or other coagulation disorder that would contraindicate obtaining multiple cervical biopsies
• Subject is concurrently enrolled in clinical studies of investigational agents or studies involving collection of cervical specimens
• Subject has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate
• Subject has clinical evidence of gross purulent cervicitis
• Subject has a recent history of acute cervicitis
• Subject does not have an intact cervix uteri or has more than one cervix uteri

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Standard and polarized light colposcopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine whether polarized light increases the sensitivity and specificity over unpolarized light, the area under a receiver operating characteristic curve (AROC) will be calculated.	We will examine 300 women scheduled for colposcopy using unpolarized and polarized light. To determine whether polarized light increases the sensitivity and specificity over unpolarized light, the area under a receiver operating characteristic curve (AROC) will be calculated. We anticipate that it will take approximately 8-10 months to enroll 300 subjects.	8-10 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
We will determine the differences in the severity of cervical neoplasia between biopsies taken using polarized and unpolarized light using a Bowker's test of symmetry.	Test the hypothesis that rates of cervical neoplasia severity detected by polarized colposcopy are greater and unpolarized colposcopy.	8-10 months

Collaborators and Investigators

• Sponsor: Augusta University
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Daron Ferris, MD, Geogia Health Sciences University

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ACTUAL): February 1, 2014
• Study Completion (ACTUAL): February 1, 2014

Study Registration Dates

• First Submitted: May 5, 2011
• First Submitted That Met QC Criteria: May 5, 2011
• First Posted (ESTIMATE): May 6, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): March 10, 2015
• Last Update Submitted That Met QC Criteria: March 9, 2015
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Colposcopy; Abnormal Pap results
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Carcinoma in Situ; Cervical Intraepithelial Neoplasia
• Other Study ID Numbers: CA156166; 1R21CA156166-01A1 (NIH)