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

HPV Infection Clinical Trial

— AI-DSS  

Official title:

Prevention and Screening Intervention Project - Towards Elimination of Cervical Cancer: Validation of Artificial Intelligence as Decision Support System in VIA

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06452004
• Other study ID #: 2022300195
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Dysplasia
• Cervix Cancer
• HPV Infection
• Papillomavirus Infections
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasms

Intervention

Diagnostic Test:
• Validation of AI-DSS in Bangladesh
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.
• Validation of AI-DSS in Uganda
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.
• Validation of AI-DSS in India
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.

Locations

Country	Name	City	State
Uganda	Mpasana	Kakumiro

Sponsors (6)

Lead Sponsor	Collaborator
University Medical Center Groningen	Female Cancer Foundation, Friendship Bangladesh, International Centre for Diarrhoeal Disease Research, Bangladesh, Manipal Academy for Higher Education, Uganda Cancer Institute

Country where clinical trial is conducted

Uganda, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	User-friendliness of AI-DSS device among healthcare providers	Scoring on Likert scale by healthcare providers using AI-DSS device based on their assessment of device software human machine interface, weight, size, flashlight,	through study completion, estimated 2 years
Primary	Accuracy, sensitivity, specificity of AI-DSS	Measurement of true and false positive and true and false negative results of the AI DSS in relation to assessment by expert panel	through study completion, estimated 2 years
Secondary	Percentage of quality pictures	Percentage of pictures taken during the VIA procedures, which meet according to the expert panel the quality standards suitable for AI-DSS assessment, based on visibility of cervix and Squamo-Columnar Junction (SCJ), light, reflection of speculum, mucus-free surface	through study completion, estimated 2 years