Low-cost Imaging Technology 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.

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Key information

Conditions

Cervical Intraepithelial Neoplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neoplasms Precancerous Conditions Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Diseases

Age range

25 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Multimodal Mobile Colposcope (MMC)

Device

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.

Primary outcomes

Develop and validate a Multimodal Mobile Colposcope (MMC)

Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Júlio César P Resende, MD, PhD

CONTACT

[email protected]

+55 (17) 3321-6600 ext. 7086

Mila P Salcedo, MD, PhD

CONTACT

[email protected]

+1-832-316-3774

Sponsors and collaborators

Lead sponsor

Barretos Cancer Hospital

Other

Collaborators

Irmandade Santa Casa de Misericórdia de Porto Alegre
M.D. Anderson Cancer Center
William Marsh Rice University

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2025
First posted: Oct 14, 2021
Registry last updated: Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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