NCT05078528 Low-cost Imaging Technology for Global Prevention of Cervical Cancer
| NCT ID | NCT05078528 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Barretos Cancer Hospital |
| Condition | Cervical Intraepithelial Neoplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,060 participants |
| Start Date | 2021-09-20 |
| Primary Completion | 2025-08-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,060 participants in total. It began in 2021-09-20 with a primary completion date of 2025-08-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05078528 clinical trial?
This trial is open to female participants only, aged 25 Years or older, studying Cervical Intraepithelial Neoplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05078528 currently recruiting?
Yes, NCT05078528 is actively recruiting participants. Contact the research team at julio.possati@uol.com.br for enrollment information.
Where is the NCT05078528 trial being conducted?
This trial is being conducted at Porto Alegre, Brazil, Barretos, Brazil.
Who is sponsoring the NCT05078528 clinical trial?
NCT05078528 is sponsored by Barretos Cancer Hospital. The trial plans to enroll 1,060 participants.