Cervical Intraepithelial Neoplasia
Conditions
Keywords
image analysis, cancer prevention, cervical intraepithelial neoplasia
Brief summary
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.
Interventions
DEVICEMultimodal 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.
Sponsors
William Marsh Rice University
M.D. Anderson Cancer Center
Irmandade Santa Casa de Misericórdia de Porto Alegre
Barretos Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Develop and validate a Multimodal Mobile Colposcope (MMC) | Day 1 - at the colposcopy day | 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) |
Countries
Brazil
Contacts
Primary ContactJúlio César P Resende, MD, PhD
Backup ContactMila P Salcedo, MD, PhD
Outcome results
None listed