Developing a low-cost imaging device to prevent cervical cancer
Low-cost Mobile Colposcopy and Confocal Imaging for Global Prevention of Cervical Cancer
NA · Barretos Cancer Hospital · NCT05078528
This study is testing a new, affordable imaging device to help women over 25 get better screenings for cervical cancer in places that lack medical resources.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1060 (estimated) |
| Ages | 25 Years and up |
| Sex | Female |
| Sponsor | Barretos Cancer Hospital (other) |
| Locations | 2 sites (Porto Alegre, Rio Grande do Sul and 1 other locations) |
| Trial ID | NCT05078528 on ClinicalTrials.gov |
What this trial studies
This study aims to create and validate a low-cost Multimodal Mobile Colposcope (MMC) designed for cervical cancer prevention in low-resource settings. The MMC combines the imaging capabilities of a mobile colposcope with those of a fiber-optic confocal imaging probe to enhance diagnostic accuracy. By addressing the lack of clinical expertise and infrastructure in these regions, the study seeks to improve screening and diagnosis of cervical intraepithelial neoplasia. The intervention targets women over 25 who are undergoing colposcopy due to abnormal cervical screening results.
Who should consider this trial
Good fit: Ideal candidates for this study are women over 25 years of age undergoing colposcopy due to abnormal cervical screening or a history of dysplasia.
Not a fit: Patients who may not benefit from this study include those under 25 years of age or those who have undergone a hysterectomy with cervix removal.
Why it matters
Potential benefit: If successful, this study could significantly improve cervical cancer screening and prevention in low-resource settings, potentially saving many lives.
How similar studies have performed: Other studies have shown promise in developing low-cost diagnostic tools for cervical cancer, indicating that this approach has potential for success.
Eligibility criteria
Show full inclusion / exclusion 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;
Where this trial is running
Porto Alegre, Rio Grande do Sul and 1 other locations
- Irmandade Santa Casa de Misericórdia de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil (RECRUITING)
- Barretos Cancer Hospital — Barretos, São Paulo, Brazil (RECRUITING)
Study contacts
- Study coordinator: Júlio César P Resende, MD, PhD
- Email: julio.possati@uol.com.br
- Phone: +55 (17) 3321-6600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cervical Intraepithelial Neoplasia, image analysis, cancer prevention, cervical intraepithelial neoplasia