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

NCT06452004 | Active Not Recruiting DMC

• 1 other identifier: 2022300195
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

HPV Infection; Cervix Cancer; Cervical Dysplasia

Keywords

Visual Inspection cervix; Artificial Intelligence; Screening Cervical Cancer; decision support system

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of quality pictures

  through study completion, estimated 2 years

Other Outcomes (1)

• User-friendliness of AI-DSS device among healthcare providers

  through study completion, estimated 2 years

Study Arms (3)

AI-DSS validation Bangladesh

EXPERIMENTAL

Women in selected intervention area in Bangladesh, who tested hrHPV-positive eligible for VIA, are included. VIA is performed. During VIA the health worker performs an assessment. With the device a picture and taken and AI-DSS generates and assessment as well. The pictures are also assessed by an expert panel.

Diagnostic Test: Validation of AI-DSS in Bangladesh

AI-DSS validation Uganda

EXPERIMENTAL

Women in selected intervention area in Uganda, who tested hrHPV-positive eligible for VIA, are included. VIA is performed. During VIA the health worker performs an assessment. With the device a picture and taken and AI-DSS generates and assessment as well. The pictures are also assessed by an expert panel.

Diagnostic Test: Validation of AI-DSS in Uganda

AI-DSS validation India

EXPERIMENTAL

Women in selected intervention area in India, who tested hrHPV-positive eligible for VIA, are included. VIA is performed. During VIA the health worker performs an assessment. With the device a picture and taken and AI-DSS generates and assessment as well. The pictures are also assessed by an expert panel.

Diagnostic Test: Validation of AI-DSS in India

Interventions

Validation of AI-DSS in Bangladesh DIAGNOSTIC_TEST

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.

AI-DSS validation Bangladesh

Validation of AI-DSS in Uganda DIAGNOSTIC_TEST

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.

AI-DSS validation Uganda

Validation of AI-DSS in India DIAGNOSTIC_TEST

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.

AI-DSS validation India

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Uganda Cancer Institute: collaborator
• Female Cancer Foundation: collaborator
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator
• Manipal Academy for Higher Education: collaborator
• Friendship Bangladesh: collaborator

Study Sites (1)

Mpasana

Kakumiro, Uganda

Location

Related Publications (2)

• 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.

  PMID: 35840949 BACKGROUND

• 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.

  PMID: 37666527 BACKGROUND

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms; Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Precancerous Conditions

Study Officials

• Jelle Stekelenburg, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

• Janine de Zeeuw, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

• Jogchum Beltman, MD, PhD

  Female Cancer Foundation

  PRINCIPAL INVESTIGATOR

• Keerthana Prasad, PhD

  Manipal Academy for Higher Education

  PRINCIPAL INVESTIGATOR

• Carol Nakisige, MD

  Uganda Cancer Institute

  PRINCIPAL INVESTIGATOR

• Aminur Rahman Shaheen, PhD

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: June 11, 2024
• Study Start: October 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: April 4, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After 1 January 2024
• Access Criteria: As per Open Research Protocol, on request to Principal Investigator UMCG

Locations

UG (1)