Cervical Cancer Screening Study in Brazil
This trial is active, not recruiting.
|Treatments||wide-field white light imaging, acetic acid, proflavine solution, wide-field fluorescence imaging|
|Sponsor||M.D. Anderson Cancer Center|
|Start date||June 2013|
|End date||June 2018|
|Trial size||357 participants|
|Trial identifier||NCT02335372, 2011-0396, NCI-2015-00339|
Primary Objective: To perform a pilot clinical study to test multi-modal optical imaging for detection of cervical neoplasia in Brazil.
Secondary Objective: Analyze clinical data to establish the imaging modes which demonstrate the highest degree of correlation with disease state.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Area Under the Receiver Operating Characteristic (ROC) Curve for Classifying Cervical Tissue into One of 2 Diagnostic Categories
time frame: 1 day
Female participants at least 18 years old.
Inclusion Criteria: 1. Patients undergoing colposcopy 2. 18 years of age or older 3. Negative pregnancy test 4. Subjects must be willing and able to provide informed consent Exclusion Criteria: 1. Patients under 18 years of age 2. Positive pregnancy test 3. Subjects unwilling and unable to provide informed consent
|Official title||A Pilot Study of a Low-Cost Optical Imaging Tool for Cervical Cancer Screening in Brazil|
|Principal investigator||Kathleen Schmeler, MD|
|Description||Wide-field and high-resolution images of precancerous cervical lesions and normal uterine cervix will be obtained by imaging 357 patients, recruited from women presenting for colposcopic evaluation from the Prevention Department at Barretos Cancer Hospital, a MDACC Sister Institution, in Barretos, Brazil. Barretos Cancer Hospital will serve as the lead site for the study Initial wide-field white light images will be acquired in unpolarized and cross-polarized modes before application of 3-6% acetic acid. Routine colposcopy involves visual inspection of the cervix for aceto-whitening and will be followed by a second pair of white-light images in each polarization mode. The clinician will identify all sites required for biopsy according to clinical impression, marking each location on the recorded unpolarized white light image. Topical application of 0.01% proflavine solution will then be applied for 1 minute, after which wide-field imaging in fluorescence mode will be performed. The clinician will then select up to 2 additional sites for biopsy based on the appearance of this wide-field fluorescence image, recording the location of each. The high-resolution microendoscope will then be used to acquire images at all sites selected for biopsy, followed by collection of biopsy specimens. The entire imaging procedure should add less than 10 minutes to the standard colposcopy procedure.|
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