Brief Title
Clinical Evaluation of Polarized Light Assisted Colposcopy
Official Title
Clinical Evaluation of Polarized Light Assisted Colposcopy
Brief Summary
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.
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
Primary Outcome
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.
Secondary Outcome
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.
Condition
Cervical Intraepithelial Neoplasia
Study Arms / Comparison Groups
Standard and polarized light colposcopy
Description: Standard and polarized light colposcopy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
330
Start Date
April 2011
Completion Date
February 2014
Primary Completion Date
February 2014
Eligibility Criteria
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Daron Ferris, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01349621
Organization ID
CA156166
Secondary IDs
1R21CA156166-01A1
Responsible Party
Principal Investigator
Study Sponsor
Augusta University
Collaborators
National Institutes of Health (NIH)
Study Sponsor
Daron Ferris, MD, Principal Investigator, Geogia Health Sciences University
Verification Date
September 2012