Cervical Intraepithelial Neoplasia Clinical Trial
Official title:
Low-cost Mobile Colposcopy and Confocal Imaging for Global Prevention of Cervical Cancer
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.
Status | Recruiting |
Enrollment | 1060 |
Est. completion date | December 3, 2025 |
Est. primary completion date | April 3, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 25 Years and older |
Eligibility | Inclusion Criteria: - Women >25 years of age; - Women undergoing colposcopy due to abnormal cervical screening or follow-up for a history of dysplasia; - Women of childbearing potential must have a negative urine or blood pregnancy test; - Ability to understand and willingness to provide informed consent by signing specific Informed Consent Document. Exclusion Criteria: - Women under 25 years of age; - Women who have undergone hysterectomy with removal of the cervix; - Women with known allergy to proflavine or acriflavine; - Women who are pregnant or nursing at the time of enrollment; - Incapacitated women or in vulnerable situations or who are not willing to give consent; |
Country | Name | City | State |
---|---|---|---|
Brazil | Barretos Cancer Hospital | Barretos | São Paulo |
Brazil | Irmandade Santa Casa de Misericórdia de Porto Alegre | Porto Alegre | Rio Grande Do Sul |
Lead Sponsor | Collaborator |
---|---|
Barretos Cancer Hospital | Irmandade Santa Casa de Misericórdia de Porto Alegre, M.D. Anderson Cancer Center, William Marsh Rice University |
Brazil,
Hunt B, Fregnani JHTG, Brenes D, Schwarz RA, Salcedo MP, Possati-Resende JC, Antoniazzi M, de Oliveira Fonseca B, Santana IVV, de Macedo Matsushita G, Castle PE, Schmeler KM, Richards-Kortum R. Cervical lesion assessment using real-time microendoscopy ima — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | Day 1 - at the colposcopy day |
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