Automated Cervical Cancer Screening Using a Smartphone-based Artificial Intelligence Classifier

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04859530
• Other study ID #: 2017-01110b
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: September 30, 2025

Study information

• Verified date: May 2023
• Source: University Hospital, Geneva
• Contact: Patrick Petignat, Pr
• Phone: +41796630546
• Email: patrick.petignat[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5886
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• HPV
• Uterine Cervical Neoplasms

Intervention

Diagnostic Test:
• AVC 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.

Locations

Country	Name	City	State
Cameroon	Dschang District Hospital	Dschang	Menoua

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Patrick Petignat

Country where clinical trial is conducted

Cameroon, 

References & Publications (2)

Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. Erratum In: CA Cancer J Clin. 2020 Jul;70(4):313. — View Citation

Bruni L, Diaz M, Barrionuevo-Rosas L, Herrero R, Bray F, Bosch FX, de Sanjose S, Castellsague X. Global estimates of human papillomavirus vaccination coverage by region and income level: a pooled analysis. Lancet Glob Health. 2016 Jul;4(7):e453-63. doi: 10.1016/S2214-109X(16)30099-7. Erratum In: Lancet Glob Health. 2017 Jul;5(7):e662. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimate accuracy of the AVC test	by including metrics such as sensitivity, specificity, positive predictive value and negative predictive value using histologic assessment as reference standard.	2 years
Secondary	Compare accuracy of the AVC test and VIA to detect cervical precancer and cancer	using histopathology as gold standard.	2 years
Secondary	Compare accuracy of the AVC test and cytology to detect cervical precancer and cancer	using histopathology as gold standard.	2 years
Secondary	Estimate feasibility of the AVC test	by women and healthcare providers using qualitative and quantitative methods.	2 years
Secondary	Estimate acceptability of the AVC test	by women and healthcare providers using qualitative and quantitative methods.	2 years