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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05078528
Other study ID # 38969820.9.1001.5437
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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;

Study Design


Related Conditions & MeSH terms


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
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