Mobile phone in oral cancer detection in rural settings
Not Applicable
- Conditions
- Health Condition 1: K132- Leukoplakia and other disturbancesof oral epithelium, including tongueHealth Condition 2: K135- Oral submucous fibrosis
- Registration Number
- CTRI/2023/09/057181
- Lead Sponsor
- ational Institutes of Health, United States
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. ALl individuals above 18 years and having Clinically suspicious oral lesions which are indicated for biopsy.
Exclusion Criteria
1. Individuals less than 18 years
2. Pregnant women
3. Individuals currently undergoing treatment for malignancy
4. Individuals having acute illness or undergoing treatment for tuberculosis
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proposed dual mode intraoral imaging system will deliver new & imperatively <br/ ><br>needed capabilities to the end users in low resource setting. This artificial intelligence <br/ ><br>integrated system will: (1) detect suspicious regions with high sensitivity & specificity; <br/ ><br>(2) enable automatic, accurate, & objective in situ diagnosis; & in screening program <br/ ><br>settings or nodal center settings, the device will triage suspicious or non-suspicious <br/ ><br>lesions. <br/ ><br>Timepoint: 1. Optimize a mobile imaging system for low-resource setting in year 1 <br/ ><br>2. Develop mobile based deep learning image classification in year 1 <br/ ><br>3. Validate the clinical usefulness of the mobile imaging system in year 2
- Secondary Outcome Measures
Name Time Method Final outcome of the study is to achieve Diagnostic sensitivity & specificity of: 1) 95 <br/ ><br>% for distinguishing OSCC from healthy sites; (2) 90% for distinguishing OPML from <br/ ><br>healthy tissues; and (3) 85% for distinguishing non-neoplastic lesion from healthy, oral cancer, or OPML tissues.Timepoint: The diagnostic accuracy, sensitivity & specificity will be achieved at the end of second year