Low-cost Imaging Technology for Global Prevention of Cervical Cancer

Cervical Intraepithelial Neoplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05078528
• Other study ID #: 38969820.9.1001.5437
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2021
• Est. completion date: December 3, 2025

Study information

• Verified date: February 2023
• Source: Barretos Cancer Hospital
• Contact: Júlio César P Resende, MD, PhD
• Phone: +55 (17) 3321-6600
• Email: julio.possati[@]uol.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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;

Related Conditions & MeSH terms

• Cervical Intraepithelial Neoplasia
• Neoplasms

Intervention

Device:
• Multimodal 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.

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
Barretos Cancer Hospital	Irmandade Santa Casa de Misericórdia de Porto Alegre, M.D. Anderson Cancer Center, William Marsh Rice University

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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

Outcome

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