CTRI/2024/07/071091尚未招募2/3 期
Design, Assembly, Testing, and Multi-Center Evaluation of a Miniature and Portable LIF System for Screening of Oral Malignancy.
Department of science and technology,Governmnet of INDIA3 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年8月12日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- A handheld LED based optical device for the Screening of Oral
研究概览
简要总结
The spectroscopic techniques are emerging as an effective tool for the detection of cancers in an effective way. This technique has the potential to be used as an alternative to biopsy which is called optical biopsy. This Multi center intervention study mainly aims at the development of a compact device that is capable of acting like an optical biopsy device for oral cancer screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed clinically with oral cancer or potentially malignant oral lesions (Leukoplakia/erythroplakia)
- •Presence of oral lesions suspected to be malignant or potentially malignant and requiring tissue biopsy.
- •3.No oral cancer surgery, chemotherapy or radiotherapy, or recurrences.
- •patients undergoing excision of clinically benign oral soft tissue (as in pericoronal flap excision/ gingival overgrowth excision).
- •Absence of oral lesions suspected to be malignant or potentially malignant but requiring surgical excision of oral tissue as mentioned above.
- •3.No medical contraindication for oral soft tissue excision.
排除标准
- •Patients diagnosed clinically with oral cancer or potentially malignant oral lesions (Leukoplakia/erythroplakia)
- •Presence of oral lesions suspected to be malignant or potentially malignant and requiring tissue biopsy.
- •3.No oral cancer surgery, chemotherapy or radiotherapy, or recurrences.
- •patients undergoing excision of clinically benign oral soft tissue (as in pericoronal flap excision/ gingival overgrowth excision).
- •Absence of oral lesions suspected to be malignant or potentially malignant but requiring surgical excision of oral tissue as mentioned above.
- •3.No medical contraindication for oral soft tissue excision.
结局指标
主要结局
A handheld LED based optical device for the Screening of Oral
时间窗: 3 years
Malignancy.
时间窗: 3 years
次要结局
- This device can be utilized to screen the other epithelial cancers such as cervical cancer.(1 Year)
研究者
Vineetha R
Manipal College of Dental Sciences, Manipal, MAHE
研究点 (3)
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