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

Abstract

Introduction Cervical cancer remains a major public health challenge in low- and middle-income countries (LMICs) due to financial and logistical issues. WHO recommendation for cervical cancer screening in LMICs includes 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. Its accuracy can be improved by computer-aided detection techniques. Our aim is to assess the performance of a smartphone-based Automated VIA Classifier (AVC) relying on Artificial Intelligence to discriminate precancerous and cancerous lesions from normal cervical tissue. Methods The AVC study will be nested in an ongoing cervical cancer screening program called “3T-study” (for Test, Triage and Treat), including HPV self-sampling followed by VIA triage and treatment if needed. After application of acetic acid on the cervix, precancerous and cancerous cells whiten more rapidly than non-cancerous ones and their whiteness persists stronger overtime. The AVC relies on this key feature to determine whether the cervix is suspect for precancer or cancer. In order to train and validate the AVC, 6000 women aged 30 to 49 years meeting the inclusion criteria will be recruited on a voluntary basis, with an estimated 100 CIN2+, calculated using a confidence level of 95% and an estimated sensitivity of 90% +/-7% precision on either side. Diagnostic test performance of AVC test and two current standard tests (VIA and cytology) used routinely for triage will be evaluated and compared. Histopathological examination will serve as reference standard. Participants’ and providers’ acceptability of the technology will also be assessed. The study protocol was registered under ClinicalTrials.gov (number NCT04859530). Expected results The study will determine whether AVC test can be an effective method for cervical cancer screening in LMICs.

Machine Intelligence in Africa: a survey

“…In a study [63], the focus is on a protocol for a twosite clinical trial validating a smartphone-based MI classifier for identifying cervical precancer and cancer in HPV-positive women in Cameroon. Cervical cancer remains a significant public health challenge in low-and middle-income countries (LMICs) due to financial and logistical issues.…”

Acceptability of artificial intelligence for cervical cancer screening in Dschang, Cameroon: a qualitative study on patient perspectives

“…Currently, the Swiss Federal Institute of Technology Lausanne (EPFL) and HUG are collaborating to develop an automated smartphone-based image classifier that serves as a computer aided diagnosis (CAD) tool for cancerous lesions based on videos obtained only using a smartphone application. The images that are recorded are then classified using an artificial neural network and image processing techniques that distinguish precancerous and cancerous lesions from non-neoplastic cervical tissue [ 8 ]. The results are then available on the smartphone application to healthcare professionals and can be shared with patients during consultations to support explanation and thus improve understanding.…”