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

NCT04859530 | Recruiting DMC

• 1 other identifier: 2017-01110b
• Study Type: interventional
• Target: 5,886
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Cancer; HPV

Keywords

Cervical cancer screening; HPV-related cervical precancer and cancer; Artificial Intelligence; Image processing; Automated VIA Classifier

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Compare accuracy of the AVC test and VIA to detect cervical precancer and cancer

  2 years

• Compare accuracy of the AVC test and cytology to detect cervical precancer and cancer

  2 years

• Estimate feasibility of the AVC test

  2 years

• Estimate acceptability of the AVC test

  2 years

Study Arms (1)

AVC test

EXPERIMENTAL

Diagnostic Test: AVC test

Interventions

AVC test DIAGNOSTIC_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

AVC test

Eligibility Criteria

• Age: 30 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Free and informed consent to take part in the study on a voluntary basis

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Patrick Petignat: lead

Study Sites (1)

Dschang District Hospital

Dschang, Menoua, Cameroon

RECRUITING

Related Publications (3)

• 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.

  PMID: 30207593 BACKGROUND

• 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.

  PMID: 27340003 BACKGROUND

• Baleydier 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.

  PMID: 34914727 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Neoplasms

Interventions

Vaginal Smears

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Obstetrical and Gynecological; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Patrick Petignat

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Petignat, Pr

CONTACT

+41796630546; patrick.petignat@hcuge.ch

Inès Baleydier

CONTACT

+41 77 460 61 20; ines.baleydier@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the gynaecology department

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 26, 2021
• Study Start: August 1, 2018
• Primary Completion: August 30, 2025
• Study Completion: September 30, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

CA (1)