Clinical Evaluation of Polarized Light Assisted Colposcopy

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.

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

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