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.

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Key information

Conditions

Cervical Intraepithelial Neoplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neoplasms Precancerous Conditions Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Georgia Health Sciences University

Augusta, Georgia, 30912, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Time frame: 8-10 months

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.

Secondary outcomes

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.

Time frame: 8-10 months

Test the hypothesis that rates of cervical neoplasia severity detected by polarized colposcopy are greater and unpolarized colposcopy.

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Collaborators

National Cancer Institute (NCI)
National Institutes of Health (NIH)

Registry information

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: May 6, 2011
Registry last updated: Mar 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed