Prevention and Screening Intervention Project - Towards Elimination of Cervical Cancer: Validation of Artificial Intelligence as Decision Support System in VIA
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Accuracy, sensitivity, specificity of AI-DSS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female in eligible age group
- •Women who tested HPV positive and are eligible for VIA
- •Ability to give informed consent and participate in study
排除标准
- •Clinical signs of cervical carcinoma
- •Menstruation or other vaginal blood loss
- •HPV negative women
研究组 & 干预措施
AI-DSS validation Bangladesh
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.
干预措施: Validation of AI-DSS in Bangladesh (Diagnostic Test)
AI-DSS validation Uganda
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.
干预措施: Validation of AI-DSS in Uganda (Diagnostic Test)
AI-DSS validation India
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.
干预措施: Validation of AI-DSS in India (Diagnostic Test)
结局指标
主要结局
Accuracy, sensitivity, specificity of AI-DSS
时间窗: through study completion, estimated 2 years
Measurement of true and false positive and true and false negative results of the AI DSS in relation to assessment by expert panel
次要结局
- Percentage of quality pictures(through study completion, estimated 2 years)