Clinical trial NCT06452004: Validation of Artificial Intelligence as Decision Support System in VIA (PRESCRIP-TEC)
Official title: Prevention and Screening Intervention Project - Towards Elimination of Cervical Cancer: Validation of Artificial Intelligence as Decision Support System in VIA
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HPV Infection
Cervix Cancer
Cervical Dysplasia
Keywords: Visual Inspection cervix
Artificial Intelligence
Screening Cervical Cancer
decision support system
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Uganda Cancer Institute
name: Female Cancer Foundation
name: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Manipal Academy for Higher Education
name: Friendship Bangladesh
First posted: 2024-06-11
Enrollment: 600
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In Uganda, India and Bangladesh eligible women in geographic areas are invited to perform self-test for hrHPV. hrHPV-positive women are invited for further examination of the cervix using VIA. In all VIAs pictures are taken with the device and the AI decision support system is activated. Health workers will give an independent VIA assessment before the AI assessment can be accessed. An expert panel gives an independent assessment without knowing the health worker or AI assessment.
Primary purpose: SCREENING

Brief summary: The research project is a component of another research project that applies the protocol of the World Health Organization for screening of cervical cancer, with testing of high-risk Human Papilloma Virus (hrHPV) as first screening. In the screen, triage and treat approach women who tested positive for hrHPV are undergoing Visual Inspection of the cervix with Acetic Acid (VIA). This procedure is applied in Uganda, India and Bangladesh. However the quality of VIA by lower-trained staff is variable because Low and Middle Income Countries face limited numbers of qualified health care professionals. Artificial intelligence (AI) might be a solution to improve consistency of VIA assessment. This research validates an AI decision support system (AI-DSS) under field conditions.

Detailed description: This research project aims to validate an image processing algorithm in order to study if the AI can function as decision support system (DSS) for healthcare workers, who perform VIA. The AI-DSS has been designed by the Manipal Academy of Higher Education in India and has shown a sensitivity of 99.05% and specificity of 97.16% for detection of aceto-white lesions.

The first step of the validation process is a dry run using a database of VIA pictures with pathology confirmation. The accuracy, sensitivity and specificity of healthcare workers, an expert team and the AI will be analysed, based on the ground truth of database pictures.

Thereafter, the AI-DSS will be validated under field conditions. Women who are hrHPV-positive in Uganda, India and Bangladesh will undergo a VIA. The AI is incorporated in a device, that can take pictures of the cervix and provide and instant report (positive = needs further investigation or negative = no lesions found). The user experience of the device will be evaluated.

The AI-DSS will be validated by comparing the VIA assessment by health workers, the AI with assessment by the expert panel. Accuracy, sensitivity and specificity of the AI algorithm will be assessed.

Eligibility criteria: Inclusion Criteria:

* Female in eligible age group
* Women who tested HPV positive and are eligible for VIA
* Ability to give informed consent and participate in study

Exclusion Criteria:

* Clinical signs of cervical carcinoma
* Menstruation or other vaginal blood loss
* HPV negative women

Primary outcomes:
measure: Accuracy, sensitivity, specificity of AI-DSS
timeFrame: through study completion, estimated 2 years
Secondary outcomes:
measure: Percentage of quality pictures
timeFrame: through study completion, estimated 2 years
Other outcomes:
measure: User-friendliness of AI-DSS device among healthcare providers
timeFrame: through study completion, estimated 2 years
Locations:
city: Kakumiro
country: Uganda
facility: Mpasana
Study officials:
affiliation: University Medical Center Groningen
name: Jelle Stekelenburg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Groningen
name: Janine de Zeeuw, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Female Cancer Foundation
name: Jogchum Beltman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Manipal Academy for Higher Education
name: Keerthana Prasad, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Uganda Cancer Institute
name: Carol Nakisige, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Aminur Rahman Shaheen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sultanov M, Zeeuw J, Koot J, der Schans JV, Beltman JJ, Fouw M, Majdan M, Rusnak M, Nazrul N, Rahman A, Nakisige C, Rao AP, Prasad K, Guruvare S, Biesma R, Versluis M, de Bock GH, Stekelenburg J. Investigating feasibility of 2021 WHO protocol for cervical cancer screening in underscreened populations: PREvention and SCReening Innovation Project Toward Elimination of Cervical Cancer (PRESCRIP-TEC). BMC Public Health. 2022 Jul 15;22(1):1356. doi: 10.1186/s12889-022-13488-z.
citation: Nakisige C, de Fouw M, Kabukye J, Sultanov M, Nazrui N, Rahman A, de Zeeuw J, Koot J, Rao AP, Prasad K, Shyamala G, Siddharta P, Stekelenburg J, Beltman JJ. Artificial intelligence and visual inspection in cervical cancer screening. Int J Gynecol Cancer. 2023 Oct 2;33(10):1515-1521. doi: 10.1136/ijgc-2023-004397.