Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia
NCT ID: NCT00513123
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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COMPLETED
100 participants
OBSERVATIONAL
2002-09-30
2009-02-28
Brief Summary
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Other Objectives:
* To measure digital fluorescence and reflectance images in vivo of sites in the human cervix.
* To evaluate the effect of acetic acid in the image contrast obtained.
* Compare the device performance to colposcopy and pathologic analysis of tissue removed at colposcopy.
Detailed Description
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DCF will be done during the routine colposcopy in the outpatient clinic. A digital colposcope (DC) device will be used to take a sequence of images of the cervix and vagina. (A DC is a digital camera connected to the colposcope with a specialized light source. It will shine light on the cervix and acquire a sequence images). The images will tell doctors about the cells and structure of the tissue. After the first set of images, acetic acid will be applied to the cervix so that lesions show up better, and 1-2 minutes later more readings will be taken.
Small samples of areas of abnormal tissue will be removed during colposcopy. Taking these tissue samples is a routine part of this type of exam. If patients are having colposcopy and loop electrosurgical excision procedure (LEEP treatment, one sample of normal tissue will be taken. (The cervix will be numbed for this procedure.) DCF images will be compared with lab findings from these samples. Before DCF is done, as standard of care, patients will have a complete history and physical exam, urine pregnancy test, pap smear, and cultures for gonorrhea, chlamydia and viral testing.
This is an investigational study. About 114 women will take part in this study. About 22 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 Colposcopy
Digital Colposcopy for Fluorescence (DCF)
Colposcopy
As part of routine colposcopic evaluation, patients will undergo routine colposcopy with the digital colposcope (DC) will then be used to take an image of the vagina and cervix.
Interventions
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Colposcopy
As part of routine colposcopic evaluation, patients will undergo routine colposcopy with the digital colposcope (DC) will then be used to take an image of the vagina and cervix.
Eligibility Criteria
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Inclusion Criteria
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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Lyndon B. Johnson Hospital
Houston, Texas, United States
U.T. Health Science Center
Houston, Texas, United States
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States
British Columbia Cancer Research Center
Vancouver, British Columbia, Canada
University College Hospital
Ibadan, Oyo State, Nigeria
Countries
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Related Links
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UT MD Anderson Cancer Center website
Other Identifiers
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GYN98-258
Identifier Type: -
Identifier Source: org_study_id