Validation of a low-cost cervical cancer screening test
Validation of a Lab-free Low-cost Screening Test for Prevention of Cervical Cancer: Automated Visual Evaluation
This study is testing a new, low-cost cervical cancer screening tool to see if it works as well as traditional methods for women in El Salvador.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10000 (estimated) |
| Ages | 30 Years to 59 Years |
| Sex | Female |
| Sponsor | DL Analytics Industry-sponsored |
| Locations | 1 site (San Salvador) |
| Trial ID | NCT06815939 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the Automated Visual Evaluation (AVE), specifically the CINFinder version developed by DL Analytics, as a point-of-care screening tool for cervical cancer. The study will involve a prospective paired observational design with 10,000 women in San Salvador, El Salvador, comparing the sensitivity of AVE against traditional screening methods such as HPV tests and visual inspection with acetic acid. The goal is to improve cervical cancer screening in low-and middle-income countries where resources are limited and the disease burden is high.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 30 to 59 years living in San Salvador, El Salvador.
Not a fit: Patients who have had a hysterectomy, are currently pregnant, or have had a cervical cancer diagnosis or treatment in the last 5 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accessible and effective screening method for cervical cancer, potentially reducing mortality rates in underserved populations.
How similar studies have performed: Other studies have explored automated visual evaluation technologies, but this specific application as a screening tool is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women between 30 and 59 years of age Exclusion Criteria: * Pregnancy at the time of colposcopy/biopsy * Hysterectomy with surgically absent cervix * HPV test in the last 5 years independently of negative or positive result * Previous cervical cancer diagnosis or treatment in the last 5 years * Lack of willingness or capacity to provide informed consent
Where this trial is running
San Salvador
- Ministerio de Salud — San Salvador, El Salvador (Recruiting)
Study contacts
- Principal investigator: Karla Alfaro, MD — Basic Health International, Inc.
- Study coordinator: David Levitz, PhD
- Email: levitz@dlanalytics.ai
- Phone: 817-966-5600
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.