Evaluation and follow-up of potentially oral precancerous lesions using mobile health technology and light-based tool
Not Applicable
- Conditions
- Health Condition 1: K132- Leukoplakia and other disturbancesof oral epithelium, including tongueHealth Condition 2: C00-C14- Malignant neoplasms of lip, oral cavity and pharynxHealth Condition 3: K135- Oral submucous fibrosis
- Registration Number
- CTRI/2021/04/032536
- Lead Sponsor
- Dr Praveen B
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Inclusion criteria-
1. All individuals aged above 18 years fulfilling at least one of the criteria-
a. Having history of risk habits (Smoking/ chewing tobacco, betel leaf/nut, alcohol)
b. Individuals with positive clinical signs (red or white patches, nonhealing ulcers of the mouth that last more than 3 weeks, restriction of mouth opening, and swelling of the neck)
c.Individuals with high Blood pressure/ Hypertension and high blood sugar level/ Diabetes
2.All individuals aged above 40 years irrespective of habits/or oral lesions
Exclusion Criteria
1. Currently undergoing treatment for malignancy
2. Pregnancy
3. Under treatment for tuberculosis or suffering from any acute illness
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.The malignant transformation rate amongst the study population <br/ ><br>2.Develop prediction model for risk assessment in progression of OPMDs <br/ ><br>3.Usefulness of objective assessment of Autofluorescence Imaging in surveillance of OPMDs. <br/ ><br>Timepoint: 1.malignant transformation will be assessed at 12 months <br/ ><br>2.Prediction model will be developed at 3 years <br/ ><br>3. Surveillance of OPMDs- at every 3 months <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.The association of diabetes/hypertension and progression of OPMDS <br/ ><br>2.The agreement between FHPs, Onsite and Remote diagnosis of oral lesions <br/ ><br>3.The agreement between remote diagnosis of oral lesions by specialists and biopsy. Biopsy in field is a challenge and compliance for biopsy expected would be low <br/ ><br>4.Prevalence of risk habits, OPMDs/ oral cancer in the study population. <br/ ><br>Timepoint: 3 years