POCTRN Point of Care Technologies for Nutrition Infection and Cancer for Global Health PORTENT Study AI based Oral Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Validity (sensitivity and specificity) of the Berry.care app in identifying oral potentially malignant disorders
研究概览
简要总结
The proposed research aims to evaluate the effectiveness of an AI-based tool for early detection of oral cancer, specifically focusing on its use in both rural and urban healthcare settings. This research is driven by the urgent need for improved screening methods, particularly in under served regions, where late-stage oral cancer diagnosis is common due to limited access to healthcare facilities. The main objectives include validating the AI tool’s accuracy in detecting precancerous lesions and early signs of oral cancer using smartphone-captured images, assessing its feasibility for integration into existing healthcare systems, and determining its potential to enhance early detection rates. The importance of this work lies in its alignment with national health priorities, particularly the need to address rising cancer rates in India and expand access to effective, non-invasive diagnostic tools. The study’s outcomes will contribute to advancing affordable, scalable solutions for oral cancer screening in India.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female participants from factory settings who attend dental camps for screening in Bangalore (Karnataka) and krishnagiri (Tamil Nadu) districts.
排除标准
- •1.Individuals with previously diagnosed and treated oral cancer will be excluded to focus on the effectiveness of the app in supporting screening processes for premalignant or early cancerous lesions.
- •2.Persons who fail the trismus test (unable to open their mouth sufficiently to insert 3 fingers), because appropriate images cannot be captured.
- •3.Persons with any major trauma / medical condition / major surgeries / facial nerve palsies/ deformity or any other condition affecting acquisition of images from the oral cavity.
结局指标
主要结局
Validity (sensitivity and specificity) of the Berry.care app in identifying oral potentially malignant disorders
时间窗: Individuals will undergo oral cancer screening once at the time of recruitment
次要结局
- Usability of the berry.care app - metrics of user satisfaction, ease of use, and time on task as well as insights for design improvements to the berry.care app will be obtained from usability tests with end users(Healthcare workers will perform usability tests on the berry.care app once at the time of recruitment.)
研究者
Dr Hari Menon
St Johns Medical College Hospital