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Automated Cervical Cancer Screening Using a Smartphone-based Artificial Intelligence 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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04859530
Enrollment
5886
Registered
2021-04-26
Start date
2018-08-01
Completion date
2025-09-30
Last updated
2025-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer, HPV

Keywords

Cervical cancer screening, HPV-related cervical precancer and cancer, Artificial Intelligence, Image processing, Automated VIA Classifier

Brief summary

Cervical cancer remains a major public health challenge in low- and middle-income countries (LMICs) due to financial and logistical issues. The World Health Organization (WHO) recommendation for cervical cancer screening in LMICs includes Human Papillomavirus (HPV) testing as primary screening followed by visual inspection with acetic acid (VIA) and treatment. However, VIA is a subjective procedure dependent on the healthcare provider's experience. Therefore, an objective approach based on quantitative diagnostic algorithms is desirable to improve performance of VIA. With this objective and in a collaboration between the Gynecology and Obstetrics Department of the Geneva University Hospital (HUG) and the Swiss Institute of Technology (EPFL), our group started the development of an automated smartphone-based image classification device called AVC (for Automatic VIA Classifier). Two-minute videos of the cervix are recorded during VIA and classified using an artificial neural network (ANN) and image processing techniques to differentiate precancer and cancer from non-neoplastic cervical tissue. The result is displayed on the smartphone screen with a delimitation map of the lesions when appropriate. The key feature used for classification is the dynamic of cervical acetowhitening during the 120 second following the application of acetic acid. Precancerous and cancerous cells whiten more rapidly than non-cancerous ones and their whiteness persists stronger overtime. Our aim is to assess the diagnostic performance of the AVC and to compare it with the performance of current triage tests (VIA and cytology). Histopathological examination will serve as reference standard. Participants' and providers' acceptability will also be considered as part of the study. The study will be nested in an ongoing cervical cancer screening program called 3T-approach (for Test, Triage and Treat) which includes HPV self-sampling for women aged 30 to 49 years, followed by VIA triage and treatment if needed. The AVC will be evaluated in this context. The study's risk category is A according to swiss ethical guidelines. This decision is based on the fact that the planned measures for sampling biological material or collecting personal data entail only minimal risks and burdens.

Interventions

DIAGNOSTIC_TESTAVC test

The AVC test will be performed during VIA by local midwives: 120 second videos focused on the cervix will be taken right after the application of acetic acid on the cervix. The recording smartphone will be fixed on a tripod situated 15cm away from the cervix.

Sponsors

Prof. Patrick Petignat
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 49 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Estimate accuracy of the AVC test2 yearsby including metrics such as sensitivity, specificity, positive predictive value and negative predictive value using histologic assessment as reference standard.

Secondary

MeasureTime frameDescription
Compare accuracy of the AVC test and VIA to detect cervical precancer and cancer2 yearsusing histopathology as gold standard.
Compare accuracy of the AVC test and cytology to detect cervical precancer and cancer2 yearsusing histopathology as gold standard.
Estimate feasibility of the AVC test2 yearsby women and healthcare providers using qualitative and quantitative methods.
Estimate acceptability of the AVC test2 yearsby women and healthcare providers using qualitative and quantitative methods.

Countries

Cameroon

Contacts

Primary ContactPatrick Petignat, Pr
patrick.petignat@hcuge.ch+41796630546
Backup ContactInès Baleydier
ines.baleydier@gmail.com+41 77 460 61 20

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026