Low-cost Imaging Technology for Global Prevention of Cervical Cancer

Study Overview
=================
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.

Official Title
-----------------
Low-cost Mobile Colposcopy and Confocal Imaging for Global Prevention of Cervical Cancer

Conditions
-----------------
Cervical Intraepithelial Neoplasia

Intervention / Treatment
-----------------
* Device: Multimodal Mobile Colposcope (MMC)


Participation Criteria
=================
Eligibility Criteria
-----------------
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;

Ages Eligible for Study
-----------------
Minimum Age: 25 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group - MMC<br>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)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
image analysis, cancer prevention, cervical intraepithelial neoplasia