Clinical Evaluation of Polarized Light Assisted Colposcopy

This study is currently recruiting participants.
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
  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.


Estimated Enrollment: 300
Study Start Date: April 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Standard and polarized light colposcopy
Standard and polarized light colposcopy

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

Contacts
Contact: Angela Goebel, BS, CCRC 706-721-2535 agoebel@georgiahealth.edu

Locations
United States, Georgia
Georgia Health Sciences University Recruiting
Augusta, Georgia, United States, 30912
Principal Investigator: Daron Ferris, MD         
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 Health Sciences University
ClinicalTrials.gov Identifier: NCT01349621     History of Changes
Other Study ID Numbers: CA156166
Study First Received: May 5, 2011
Last Updated: September 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Georgia Regents University:
Abnormal Pap results
Colposcopy

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

ClinicalTrials.gov processed this record on April 17, 2014