Low- Cost Mobile Oral Cancer Screening For Low Resource Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6,400
- 试验地点
- 3
- 主要终点
- 1. Identification of Oral precancer and cancer by Frontline healthcare providers using point of care diagnostic tool.
研究概览
简要总结
Thisproject is a multicentric study, in India at three sub-centers. The aim of this research is to empower the health care workers in ruralIndia to identify oral & pharyngeal lesions with a mobile phone. The deviceacts as “Point of Care†diagnosis for early detection of Oral Cancer andapproach creates an opportunity to connect specialists to rural population,facilitates timely referrals and follow up. Study aimed at Field validation of mobileintraoral system for Oral cancer in LMIC settings.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 95.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically Suspicious oral Lesions (Including leukoplakia, erythroplakia, Lichen planus, benign lesions- epithelial tumors, ulcers, vesiculobullous lesions like pemphigus vulgaris)
- •History of previously treated OSCC, with no current evidence of cancer recurrence at least for 6 months after cessation of treatment.
- •Presence of recently diagnosed untreated OSCC or a precancerous lesion
- •Individuals positive for tobacco habit.
排除标准
- •Less than or equal to 18 years of age
- •Currently undergoing treatment for malignancy
- •Pregnancy
- •Under treatment for tuberculosis or suffering from any acute illness.
结局指标
主要结局
1. Identification of Oral precancer and cancer by Frontline healthcare providers using point of care diagnostic tool.
时间窗: Interim analysis performed at the end of 12months to assess FHPs for identification of oral precancer and cancer using point of care diagnostic tool | At the end of two and half years to develop AI based algorithm
2. To develop an AI based diagnosis
时间窗: Interim analysis performed at the end of 12months to assess FHPs for identification of oral precancer and cancer using point of care diagnostic tool | At the end of two and half years to develop AI based algorithm
次要结局
- To evaluate the agreement between FHPs/ Onsite specialist/ Remote specialist/ AI algorithm(To evaluate the agreement between the remote diagnosis/ Biopsy)