Clinical Evaluation of Polarized Light Assisted Colposcopy

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Daron Ferris, Georgia Regents University
ClinicalTrials.gov Identifier:
NCT01349621
First received: May 5, 2011
Last updated: March 9, 2015
Last verified: September 2012
  Purpose

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.


Condition
Cervical Intraepithelial Neoplasia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Clinical Evaluation of Polarized Light Assisted Colposcopy

Resource links provided by NLM:


Further study details as provided by Georgia Regents University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 330
Study Start Date: April 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Standard and polarized light colposcopy
Standard and 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01349621

Locations
United States, Georgia
Georgia Health Sciences University
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Georgia Regents University
Investigators
Principal Investigator: Daron Ferris, MD Geogia Health Sciences University
  More Information

No publications provided

Responsible Party: Daron Ferris, Professor, Department of Family Medicine and Obstetrics and Gynecology, Georgia Regents University
ClinicalTrials.gov Identifier: NCT01349621     History of Changes
Other Study ID Numbers: CA156166, 1R21CA156166-01A1
Study First Received: May 5, 2011
Last Updated: March 9, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Georgia Regents University:
Abnormal Pap results
Colposcopy

Additional relevant MeSH terms:
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 01, 2015