Low-cost Imaging Technology for Global Prevention of Cervical Cancer

Not Applicable

Recruiting

• Conditions: Cervical Intraepithelial Neoplasia
• Interventions: Device: Multimodal Mobile Colposcope (MMC)

• Registration Number: NCT05078528
• Lead Sponsor: Barretos Cancer Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-20
• Study First Submitted: 2021-10-04
• Study First Submitted QC: 2021-10-04
• Study First Posted: 2021-10-14
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06
• Primary Completion: 2025-08-03
• Study Completion: 2025-12-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1060

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group - MMC	Multimodal Mobile Colposcope (MMC)	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.

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (2)

Irmandade Santa Casa de Misericórdia de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil

Barretos Cancer Hospital; 🇧🇷 Barretos, São Paulo, Brazil