Automated cervical cancer screening using a smartphone AI classifier
Study Protocol for a Two-site Clinical Trial to Validate a Smartphone-based Artificial Intelligence Classifier Identifying Cervical Precancer and Cancer in HPV-positive Women in Cameroon
This study is testing a smartphone app that uses AI to help improve cervical cancer screening in low- and middle-income countries by making it more accurate and easier for healthcare providers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5886 (estimated) |
| Ages | 30 Years to 49 Years |
| Sex | Female |
| Sponsor | University Hospital, Geneva Academic / other |
| Locations | 1 site (Dschang, Menoua) |
| Trial ID | NCT04859530 on ClinicalTrials.gov |
What this trial studies
This study aims to improve cervical cancer screening in low- and middle-income countries by utilizing a smartphone-based artificial intelligence classifier called AVC. The AVC system records two-minute videos of the cervix during visual inspection with acetic acid (VIA) and analyzes them using an artificial neural network to provide objective classifications. This approach seeks to enhance the accuracy of VIA, which is currently dependent on the healthcare provider's experience. The collaboration involves the Gynecology and Obstetrics Department of the Geneva University Hospital and the Swiss Institute of Technology.
Who should consider this trial
Good fit: Ideal candidates for this study are women who are eligible for cervical cancer screening and can provide informed consent.
Not a fit: Patients who have not initiated sexual intercourse, are pregnant, or have conditions that hinder cervix visualization will not benefit from this study.
Why it matters
Potential benefit: If successful, this technology could significantly enhance cervical cancer screening accuracy and accessibility in resource-limited settings.
How similar studies have performed: While the use of AI in medical diagnostics is gaining traction, this specific approach to cervical cancer screening is relatively novel and has not been extensively tested in similar contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Free and informed consent to take part in the study on a voluntary basis Exclusion Criteria: * No initiation of sexual intercourse * Pregnancy at the screening consultation * Any condition altering the cervix visualization at the screening consultation (e.g. heavy vaginal bleeding) * History of anogenital cancer or known anogenital cancer at the screening consultation * Previous hysterectomy * Not sufficiently healthy to participate in the study
Where this trial is running
Dschang, Menoua
- Dschang District Hospital — Dschang, Menoua, Cameroon (Recruiting)
Study contacts
- Principal investigator: Patrick Petignat — University Hospital, Geneva
- Study coordinator: Patrick Petignat, Pr
- Email: patrick.petignat@hcuge.ch
- Phone: +41796630546
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.