Validation of Artificial Intelligence as Decision Support System in VIA (PRESCRIP-TEC)

Trial Title: Validation of Artificial Intelligence as Decision Support System in VIA (PRESCRIP-TEC)

NCT ID: NCT06452004

Condition: HPV Infection
Cervix Cancer
Cervical Dysplasia

Conditions: Official terms:
Papillomavirus Infections
Uterine Cervical Neoplasms
Uterine Cervical Dysplasia

Conditions: Keywords:
Visual Inspection cervix
Artificial Intelligence
Screening Cervical Cancer
decision support system

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

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

Masking: None (Open Label)

Intervention:

Intervention type: Diagnostic Test
Intervention name: Validation of AI-DSS in Bangladesh
Description: VIA procedure, taking pre-colouring and post-colouring pictures. First VIA assessment by health worker, followed by AI-DSS assessment. Independent panel of gynaecologists also assessed pictures. The panel assessment serves as reference value to calculate accuracy, sensitivity and specificity of health worker and AI-DSS.
Arm group label: AI-DSS validation Bangladesh

Intervention type: Diagnostic Test
Intervention name: Validation of AI-DSS in Uganda
Description: VIA procedure, taking pre-colouring and post-colouring pictures. First VIA assessment by health worker, followed by AI-DSS assessment. Independent panel of gynaecologists also assessed pictures. The panel assessment serves as reference value to calculate accuracy, sensitivity and specificity of health worker and AI-DSS.
Arm group label: AI-DSS validation Uganda

Intervention type: Diagnostic Test
Intervention name: Validation of AI-DSS in India
Description: VIA procedure, taking pre-colouring and post-colouring pictures. First VIA assessment by health worker, followed by AI-DSS assessment. Independent panel of gynaecologists also assessed pictures. The panel assessment serves as reference value to calculate accuracy, sensitivity and specificity of health worker and AI-DSS.
Arm group label: AI-DSS validation India

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.

Criteria for 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

Gender: Female

Minimum age: 30 Years

Maximum age: 60 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Mpasana

Address:
City: Kakumiro
Country: Uganda

Start date: October 1, 2022

Completion date: December 31, 2024

Lead sponsor:
Agency: University Medical Center Groningen
Agency class: Other

Collaborator:
Agency: Uganda Cancer Institute
Agency class: Other

Collaborator:
Agency: Female Cancer Foundation
Agency class: Other

Collaborator:
Agency: International Centre for Diarrhoeal Disease Research, Bangladesh
Agency class: Other

Collaborator:
Agency: Manipal Academy for Higher Education
Agency class: Other

Collaborator:
Agency: Friendship Bangladesh
Agency class: Other

Source: University Medical Center Groningen

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06452004