An interventional study of AVC test in Cervical Cancer and HPV, sponsored by Prof. Patrick Petignat. Recruiting at 1 site in Cameroon. Open to female participants aged 30 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-29.
Sponsored by Prof. Patrick Petignat · Not applicable, Interventional, and Prevention
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.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
This study's planned enrollment of 5,886 is above the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Prof. Patrick Petignat is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: HPV self-test, VIA/VILI (visual inspection with Lugol's iodine), Pap-smear, Cervical biopsy, Endocervical brushing
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.
Time frame: 2 years
Compare accuracy of the AVC test and VIA to detect cervical precancer and cancer
using histopathology as gold standard.
Time frame: 2 years
Compare accuracy of the AVC test and cytology to detect cervical precancer and cancer
using histopathology as gold standard.
Time frame: 2 years
Estimate feasibility of the AVC test
by women and healthcare providers using qualitative and quantitative methods.
Time frame: 2 years
Estimate acceptability of the AVC test
by women and healthcare providers using qualitative and quantitative methods.
Time frame: 2 years
Started Aug 2018 (actual). Primary completion is estimated for Aug 2025, 84 months after the start.
Of 445 non-industry interventional studies with no phase under Uterine Cervical Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 71. This study's planned 84 months is above that.
Counting every sponsor, half of 461 studies reached it within 33 months; a quarter within 15 and three quarters within 71.
How these figures are worked out, and which studies are left out of them.
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Prof. Patrick Petignat