A prospective research study to collect images from oral cavity of participating subjects to test an artificial intelligence-based algorithm for supporting the early detection of oral cancers.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 661
- 试验地点
- 8
- 主要终点
- Performance metrics (Accuracy, Sensitivity, Specificity and F1 score). At Baseline & Week 2.
研究概览
简要总结
Tobacco usage in India is one of the largest preventable cause of non-communicable diseases such as oral cancer, lung cancer, obstructive lung disease and cardiovascular disease, to name a few. Consumption of tobacco in smoked forms (e.g., cigarettes, bidis, cigars, hookah) and smokeless forms (e.g., Gutkha, zarda, khaini) kills nearly a million users annually- all entirely preventable premature deaths.
With nearly 300 million current users of risky tobacco in India, of which 200 million chew smokeless tobacco, the tobacco use epidemic and the resultant deaths from cancers and other preventable diseases are unlikely to abate for the foreseeable future. The effects of smokeless tobacco are most pronounced in the oral cavity, manifesting as submucosal fibrosis, leukoplakia and oral cancers. The incidence of oral cancer in India is among the highest worldwide, comprising nearly half of all oral cancers globally. Already, smokeless tobacco kills more than 350,000 people every year in India. Particularly concerning is the disproportionately higher use of smokeless tobacco among socio-economically disadvantaged groups, women and the rural population. For example, tobacco chewing is common among migrant construction workers, those living in urban slums, truck and metro transport drivers. In the case of pregnant women chewing tobacco, their tobacco use harms them as well as their babies with an increased risk of anaemia, higher rates of stillbirth and lower weight of the newborn.
The user groups of smokeless tobacco often have a poor understanding of tobacco harms and cessation aids, along with poor access to healthcare. Cessation aids in the form of behavioural support and safer nicotine alternatives to smokeless tobacco are not affordable, accessible or available to the majority of the population.
Screening for pre-malignant and early-stage oral cancers can be done by experts by visual inspection. However, if the person at the point of care (POC) who is screening is not skilled and experienced, then the sensitivity and specificity of the visual diagnosis can be very low. This is generally the case in rural healthcare settings. As a result, tobacco user patients from rural and disadvantaged backgrounds are more likely to present late with stage III or stage IV oral cancer. Currently in India, overall survival following treatment at 5 years for Stage I oral cancer is 100% and decreases to 85% for Stage II. For Stages III and IV, 5-year survival can be a mere 43% and 42% respectively. This is further worsened due to lower affordability and access to chemotherapy and radiotherapy for most of the rural populations.
Early screening of pre-cancerous oral lesions such as Leukoplakia and Erythroplakia complemented by opportunistic and comprehensive tobacco cessation support has the potential to be a significant and impactful public health intervention. This is where ORAICLE believes that a well-designed, robustly tested and scientifically validated Artificial Intelligence (AI) algorithm can be a game-changer, and ORAICLE intends to develop an Artificial Intelligence Algorithm that can analyze images of the oral cavity at the POC and categorize the lesions as cancerous or non-cancerous and “red flag†them for further expert evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •A subject will be considered eligible in this study only if All of the following criteria apply:
- •Subject (or LAR) understands and agrees to comply with planned study procedures and provides informed consent before initiating study procedures.
- •Male or Female adults equal to or more than 18 to 65 years of age at the time of screening and enrolment.
- •Subject reporting to the site with at least one oral lesion.
排除标准
- •A subject will not be eligible for inclusion in this study if ANY of the following criteria apply:
- •If the subject has participated in another clinical trial in the last 8 weeks before coming at Visit
- •Subject having any other reason which may interfere with the study in the opinion of the Principal Investigator.
- •Subject is blind or falls under the category of vulnerable population.
- •e.g., members of a group with hierarchical structure (e.g. prisoners armed forces personnel, staff and students of medical, nursing and pharmacy academic institutions), patients with incurable diseases, unemployed or impoverished persons, patients in emergency situation, ethnic minority groups, homeless persons, nomads, refugees, minors or other incapable of personally giving consent.
- •Cancer subjects operated with reconstructive (flap) surgery.
- •Subjects with unclear oral lesion images.
- •If according to the judgment of the investigator, subject needs more than 2 biopsy(ies) for assessment after signing informed consent and oral cavity examination.
- •Subjects for whom biopsy(ies) were done for the target lesion(s) more than 30 days from the date of consent.
- •If the subject has been operated for oral cancer / or any other oral mucosal lesions.
- •Pregnant or breast-feeding female subjects.
结局指标
主要结局
Performance metrics (Accuracy, Sensitivity, Specificity and F1 score). At Baseline & Week 2.
时间窗: Performance metrics (Accuracy, Sensitivity, Specificity and F1 score). At Baseline & Week 2
次要结局
未报告次要终点
研究者
Dr Punnya S Rao
KLE Academy of Higher Education and Research