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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21CA156166-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard and polarized light colposcopy | Standard and polarized light colposcopy |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 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. | 8-10 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Test the hypothesis that rates of cervical neoplasia severity detected by polarized colposcopy are greater and unpolarized colposcopy. | 8-10 months |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy women with a previously detected abnormal cervical cytology or other indication for colposcopy
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| Name | Affiliation | Role |
|---|---|---|
| Daron Ferris, MD | Geogia Health Sciences University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia Health Sciences University | Augusta | Georgia | 30912 | United States |
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| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
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| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |