Cervical CancerNCT04859530
Automated Cervical Cancer Screening Using a Smartphone-based Artificial Intelligence Classifier
A study testing AVC test in people with Cervical Cancer and HPV, run by Prof. Patrick Petignat at 1 site in Cameroon.
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… Read more about this study
- Who is it for?
- Ages 30 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, HPV
- What is being tested?
- AVC test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,886 participants
- Where
- 1 siteCameroon
- Study dates
- 1 Aug 2018to 30 Sep 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Free and informed consent to take part in the study on a voluntary basis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cameroon1 site, 1 recruiting
- Recruiting
Dschang District Hospital
Dschang, Menoua
Bruno Kenfack, Pr, brunokenfack@gmail.com
About this study
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
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.
Read more
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.
- Conditions
- Cervical Cancer, HPV
- Being tested
- AVC test
- Keywords
- Cervical cancer screening, HPV-related cervical precancer and cancer, Artificial Intelligence, Image processing, Automated VIA Classifier
- Medical subject headings
- Uterine Cervical Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVC testDiagnostic test
Also called HPV self-test, VIA/VILI (visual inspection with Lugol's iodine), Pap-smear, Cervical biopsy
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.
| Study group | Role | What they receive |
|---|---|---|
| AVC test | Experimental | Not described Receives: Diagnostic Test: AVC test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (4)
Compare accuracy of the AVC test and VIA to detect cervical precancer and cancer
using histopathology as gold standard.
Measured: 2 years
Compare accuracy of the AVC test and cytology to detect cervical precancer and cancer
using histopathology as gold standard.
Measured: 2 years
Estimate feasibility of the AVC test
by women and healthcare providers using qualitative and quantitative methods.
Measured: 2 years
Estimate acceptability of the AVC test
by women and healthcare providers using qualitative and quantitative methods.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start1 Aug 2018
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5,886 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Patrick Petignat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Patrick Petignat, University Hospital, Geneva
- Investigators
- Patrick Petignat, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859530
- Sponsor's protocol ID
- 2017-01110b
- Other IDs
- 2017
- Status last verified
- Jan 2025
- First submitted
- 13 Apr 2021
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30207593Bruni 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.
PubMed 27340003Baleydier I, Vassilakos P, Vinals R, Wisniak A, Kenfack B, Tsuala Fouogue J, Enownchong Enow Orock G, Lemoupa Makajio S, Foguem Tincho E, Undurraga M, Cattin M, Makohliso S, Schonenberger K, Gervaix A, Thiran JP, Petignat P. 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. PLoS One. 2021 Dec 16;16(12):e0260776. doi: 10.1371/journal.pone.0260776. eCollection 2021.
PubMed 34914727