Digital Imaging Aid for Assessment of Cervical Dysplasia
NCT ID: NCT00511758
Last Updated: 2012-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
3 participants
OBSERVATIONAL
2007-06-30
2009-05-31
Brief Summary
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The specific aims of the study are:
* To compare polarized and green filtered digital images of the cervix, to standard white light images, colposcopic evaluation and to pathologic analysis of biopsied tissue.
* To develop algorithms to discriminate between normal and abnormal tissue based on digital images of the cervix.
* To analyze digital images to determine which types of optical information yield the most diagnostically useful data.
Detailed Description
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VISUAL DETECTION OF PRECANCEROUS LESIONS:
Reflectance (the ability of an area to reflect light) imaging helps doctors visually tell the difference between precancerous tissue, cancerous tissue, and normal tissue in the cervix. Researchers want find out whether a digital camera image can be as effective as colposcopy at screening for precancerous tissue.
STUDY PARTICIPATION:
You will be seen in the clinic during a routine visit. Your cervix will first be examined by the clinician using a standard white light headlamp, and the image will be recorded.
Your cervix will then be re-examined with the digital camera, which will involve the use of different types of light (standard white light, green filtered light, cross and parallel polarized light). These digital images will be taken before and after acetic acid (vinegar) is applied.
Researchers will use these images to make comparison studies with the colposcopy procedure.
LENGTH OF STUDY:
Your participation will be finished on this study once your cervix has been examined with the digital camera.
This is an investigational study. Up to patients 20 will take part in this study. All will be enrolled at M. D. Anderson.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Digital Imaging Device
Patients with a diagnosis of cervical dysplasia that are scheduled for a colposcopy.
Digital Imaging
Images of the cervix will be taken using different types of light and compared with the colposcopy procedure.
Interventions
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Digital Imaging
Images of the cervix will be taken using different types of light and compared with the colposcopy procedure.
Eligibility Criteria
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Inclusion Criteria
* Patients must sign an informed consent indicating awareness of the investigational nature of this study.
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Michele Follen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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U.T.M.D. Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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MD Anderson Cancer Center
Other Identifiers
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2007-0230
Identifier Type: -
Identifier Source: org_study_id