An interventional study of Multimodal Mobile Colposcope (MMC) in Cervical Intraepithelial Neoplasia, sponsored by Barretos Cancer Hospital. Recruiting at 2 sites in Brazil. Open to female participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2025-02-06.
Sponsored by Barretos Cancer Hospital · Not applicable, Interventional, and Prevention
Cervical cancer remains the first or second leading cause of cancer death among women in many low-and middle-income countries. Cervical cancer prevention programs in low-resource settings are hampered by a lack of personnel with appropriate clinical expertise, lack of pathology services, and lack of associated infrastructure. There is an urgent need for appropriate diagnostic tools to enable accurate screening and diagnosis in low-resource settings. The purpose of this study is to develop and validate a low-cost Multimodal Mobile Colposcope (MMC) for global cervical cancer prevention programs. This new device will combine the imaging capabilities of a mobile colposcope with the microscopic imaging capabilities of a fiber-optic confocal imaging probe.
Exclusion Criteria:
Imaging of study participants will be performed during the colposcopy examination. The mobile colposcope and the confocal imaging probe, together referred to as the Multimodal Mobile Colposcope (MMC), will be used to image and/or record videos the cervix. Cervical biopsies will be performed using biopsy forceps per standard protocols.
Device: Multimodal Mobile Colposcope (MMC)
Women referred for colposcopy due to abnormal cervical screening or follow-up for a history of dysplasia will be recruited into the experimental group of the study. Imaging of study participants will take place during the colposcopy examination.
Develop and validate a Multimodal Mobile Colposcope (MMC)
Image data will be used as a training set to develop and refine image analysis algorithms. Multimodal Mobile Colposcope will be compared with colposcopic impression considering clinical performance (sensitivity, specificity, positive and negative predictive values, and area under the Receiver Operating Characteristic (ROC) curve)
Time frame: Day 1 - at the colposcopy day
Plan to share: No
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Barretos Cancer Hospital