Clinical Evaluation of Polarized Light Assisted Colposcopy

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Georgia Regents University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Daron Ferris, Georgia Health Sciences University
ClinicalTrials.gov Identifier:
NCT01349621
First received: May 5, 2011
Last updated: September 25, 2012
Last verified: September 2012

May 5, 2011
September 25, 2012
April 2011
April 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01349621 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Test the hypothesis that rates of cervical neoplasia severity detected by polarized colposcopy are greater and unpolarized colposcopy.
Same as current
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Clinical Evaluation of Polarized Light Assisted Colposcopy
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.

Not Provided
Observational
Time Perspective: Prospective
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Non-Probability Sample

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

Cervical Intraepithelial Neoplasia
Not Provided
Standard and polarized light colposcopy
Standard and polarized light colposcopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact: Angela Goebel, BS, CCRC 706-721-2535 agoebel@georgiahealth.edu
United States
 
NCT01349621
CA156166
No
Daron Ferris, Georgia Health Sciences University
Georgia Regents University
National Institutes of Health (NIH)
Principal Investigator: Daron Ferris, MD Geogia Health Sciences University
Georgia Regents University
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP