Clinical Evaluation of Polarized Light Assisted Colposcopy
This study is currently recruiting participants.
Verified September 2012 by Georgia Regents University
Sponsor:
Georgia Regents University
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
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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 May 19, 2013