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

January 28, 2025 updated by: Prof. Patrick Petignat

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

5886

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AVC test
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.
Other Names:
  • HPV self-test
  • VIA/VILI (visual inspection with Lugol's iodine)
  • Pap-smear
  • Cervical biopsy
  • Endocervical brushing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimate accuracy of the AVC test
Time Frame: 2 years
by including metrics such as sensitivity, specificity, positive predictive value and negative predictive value using histologic assessment as reference standard.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare accuracy of the AVC test and VIA to detect cervical precancer and cancer
Time Frame: 2 years
using histopathology as gold standard.
2 years
Compare accuracy of the AVC test and cytology to detect cervical precancer and cancer
Time Frame: 2 years
using histopathology as gold standard.
2 years
Estimate feasibility of the AVC test
Time Frame: 2 years
by women and healthcare providers using qualitative and quantitative methods.
2 years
Estimate acceptability of the AVC test
Time Frame: 2 years
by women and healthcare providers using qualitative and quantitative methods.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Patrick Petignat

Investigators

  • Principal Investigator: Patrick Petignat, University Hospital, Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Estimated)

August 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

April 13, 2021

First Submitted That Met QC Criteria

April 21, 2021

First Posted (Actual)

April 26, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-01110b

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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